Prostate Cancer

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Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study


Condition: Prostate Cancer, Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06056830

Sponsor: Clarity Pharmaceuticals Ltd

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • At least 18 years of age.
  • Signed informed consent.
  • Untreated, histologically confirmed adenocarcinoma of the prostate.
  • High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
  • Patients electing to undergo RP with PLND.

Exclusion Criteria:

  • Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
  • Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  • Patients with known predominant small cell or neuroendocrine PC.

View trial on ClinicalTrials.gov


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Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)


Condition: Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04423211

Sponsor: ECOG-ACRIN Cancer Research Group

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • STEP 0: REGISTRATION ELIGIBILITY CRITERIA
  • Patient must be male and >= 18 years of age.
  • Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
  • Patient must have biochemical recurrence (BCR) after RP, defined as follows:
  • If time to BCR, defined as time to first detectable PSA ( > lower limit of normal for assay used) after RP, is < 12 months, a minimum PSA level of >= 0.2 ng/mL and a confirmatory reading of >= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible)
  • If time to BCR, defined as time to first detectable PSA (> lower limit of normal for assay used) after RP, is >= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
  • If the patient has a detectable PSA (> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement
  • Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions
  • Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration
  • Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration
  • Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.
  • Patient must not be enrolled in another therapeutic clinical trial
  • Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
  • Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI
  • Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration
  • Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
  • Hemoglobin (Hgb) >= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
  • Leukocytes >= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Absolute neutrophil count >= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Platelets >= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, must have a direct bilirubin of < 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)
  • Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
  • Patient must not have completed a course of prior pelvic radiation therapy for any reason
  • Patient must agree not to father children while on study
  • Patient must be English or Spanish speaking to be eligible for the QOL component of the study
  • NOTE: Sites cannot translate the associated QOL forms
  • STEP 1: RANDOMIZATION

Eligibility Criteria:

  • Patient must be male and >= 18 years of age.
  • Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
  • Patient must have biochemical recurrence (BCR) after RP, defined as follows:
  • If time to BCR, defined as time to first detectable PSA ( > lower limit of normal for assay used) after RP, is < 12 months, a minimum PSA level of >= 0.2 ng/mL and a confirmatory reading of >= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible)
  • If time to BCR, defined as time to first detectable PSA (> lower limit of normal for assay used) after RP, is >= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
  • If the patient has a detectable PSA (> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement
  • Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions
  • Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration
  • Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration
  • Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.
  • Patient must not be enrolled in another therapeutic clinical trial
  • Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
  • Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI
  • Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration
  • Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
  • Hemoglobin (Hgb) >= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
  • Leukocytes >= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Absolute neutrophil count >= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Platelets >= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, must have a direct bilirubin of < 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)
  • Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
  • Patient must not have completed a course of prior pelvic radiation therapy for any reason
  • Patient must agree not to father children while on study
  • Patient must be English or Spanish speaking to be eligible for the QOL component of the study
  • NOTE: Sites cannot translate the associated QOL forms
  • STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
  • Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration
  • For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
  • For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields [prostate bed +/- typical whole pelvis]), the number of extra-pelvic lesions must be known (1
  • 5 or > 5 extra-pelvic lesions)

View trial on ClinicalTrials.gov


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A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)


Condition: Metastatic Castrate-sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05884398

Sponsor: Janssen Research & Development, LLC

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI] demonstrating greater than equal (>=) 2 distinct extraprostatic sites of metastasis
  • Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
  • A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
  • Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
  • Assigned male at birth, inclusive of all gender identities
  • Participants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care

Exclusion Criteria:

  • History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
  • Pelvic lymph nodes as only site of metastasis
  • Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
  • Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
  • Gastrointestinal disorder affecting absorption

View trial on ClinicalTrials.gov


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A Phase 2 Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With BRCA1/2 Gene Alterations (NePtune)


Condition: Prostate Cancer, BRCA1 Mutation, BRCA2 Mutation, Prostatic Adenocarcinoma, High-Risk Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05498272

Sponsor: Rana McKay, MD

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Subject must meet all of the following applicable inclusion criteria to participate in this study:
  • Written informed consent and HIPAA authorization for release of personal health information prior to registration.
  • Age ≥ 18 years at the time of consent.
  • T stage 1-3 prostatic adenocarcinoma per AJCC staging manual Ed8.
  • Histologically confirmed adenocarcinoma of the prostate without histological variants comprising >50% of the sample. Patients with intraductal carcinoma are eligible.
  • Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within 7 months from registration. Less than 3 core biopsies are allowed if the patient has >1 cm or T3 disease on magnetic resonance imaging (MRI).
  • Localized unfavorable intermediate or high-risk prostate cancer patients. Patients must have at least one of the following features:
  • Gleason ≥ 4+3 (grade group 3, 4, 5) OR
  • PSA > 20 ng/dL OR
  • T3 disease NOTE: Patients with intraductal carcinoma are eligible independent of Gleason score, PSA and T stage.
  • Must have evidence of germline or somatic BRCA1/2 gene alteration via standard of care CLIA based assay detection. Testing will be confirmed centrally but results of central testing not required for enrollment.
  • No evidence of metastatic disease as determined by radionuclide bone scan and CT/MRI. Lymph nodes must be less than 20 mm in the short (transverse) axis.
  • Participants must be candidates for RP and considered surgically resectable by urologic evaluation.
  • ECOG Performance Status of 0-1 within 28 days prior to registration.
  • Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.
  • White blood cell count ≥ 3,000/mcL
  • Absolute neutrophil count ≥ 1,500/mcL
  • Hemoglobin ≥ 10 g/dL with no transfusion support in the past 28 days
  • Platelets ≥ 100,000/mcL
  • Aspartate aminotransferase, alanine aminotransferase, and total bilirubin ≤ 1.5 x Institutional upper limit of normal
  • Calculated creatinine clearance ≥ 51 mL/min based on Cockcroft-Gault formula or 24 hour urine. NOTE: See the protocol for Cockcroft-Gault formula or 24 hour urine.
  • Life expectancy≥ 16 weeks.
  • Subjects must use a condom plus spermicide beginning prior to treatment Cycle 1 Day 1, during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. See protocol for additional details.
  • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

  • Subjects meeting any of the criteria below may not participate in the study:
  • Active infection requiring systemic therapy.
  • Prior treatments not allowed: hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, apalutamide and others), CYP17 inhibitors (including abiraterone, TAK-700, galeterone, ketoconazole, and others), estrogens and radiation therapy. Prior bicalutamide is allowed if taken for < 4 weeks prior to registration and there is a washout period of 2 weeks prior to the initiation of study treatment. LHRH agonist/antagonist therapy is allowed if begun within 4 weeks of registration. Prior 5-alpha reductase inhibitors are allowed but require a washout period of 2 weeks to initiation of study treatment.
  • Prior treatment with a PARP inhibitor.
  • Hypogonadism or severe androgen deficiency as defined by screening serum testosterone < 200 ng/dL.
  • Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:
  • tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice).
  • Known active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody at screening. Testing is not required unless there was a prior known positive hepatitis B or C test or hepatitis is suspected at screening. Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Known to have tested positive for human immunodeficiency virus (HIV) unless currently on effective anti-retroviral therapy with an undetectable viral load within 6 months.
  • Severe hepatic impairment (Child-Pugh Class C).
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Pre-existing condition that warrants long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily. Physiologic replacement is permitted. Topical, intra-articular steroids or inhaled corticosteroids are permitted.
  • Active cardiac disease, defined as:
  • Myocardial infarction within 6 months of study treatment.
  • Uncontrolled angina within 3 months of study treatment.
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless an echocardiogram performed within 3 months of the screening visit results in a left ventricular ejection fraction that is ≥ 45%.
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes)
  • Other clinically significant cardiovascular disease within 6 months of registration.
  • Uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
  • Individuals with a history of another malignancy are not eligible if the cancer is under active treatment or the cancer can be seen on radiology scans or if they are off cancer treatment but in the opinion of their oncologist have a high risk of relapse within 5 years.
  • Major surgery within 4 weeks from start of treatment. Subjects must have recovered from any effects as the surgery as assessed by investigator discretion.
  • Treatment with any investigational drug within 28 days prior to registration.
  • Persistent toxicities Grade > 2 caused by previous cancer therapy (per Common Terminology Criteria for Adverse Event (CTCAE)).
  • Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorders that prohibits obtaining informed consent.
  • Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
  • Concomitant use of known strong CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks.
  • Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to the protocol).
  • Patients with a known hypersensitivity to olaparib or any of the excipients of the product.

View trial on ClinicalTrials.gov


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A Phase I/II Study of M9241 With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and M9241 With Docetaxel in Castration Resistant Prostate Cancer


Condition: Cancer Of Prostate, Prostate Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04633252

Sponsor: National Cancer Institute (NCI)

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Participants must have documented histopathological confirmation of prostate cancer. If no pathologic specimen is available, participants may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
  • Participants must have metastatic disease, defined as at least one lesion on TC99 bone scan or at least one lesion that is measurable per, per RECIST 1.1.
  • mCSPC participants:
  • Participants must be within 134 days of starting ADT.
  • If participants are on ADT and responding, this may impact the findings on scans. Pre- treatment scans could be used to confirm that participants have metastatic high-volume disease in such cases.
  • For Cohorts 1 and 2, Dose escalation and Safety Run-in, only: mCSPC may have high or low volume disease.
  • For Cohort 3, Dose Expansion: mCSPC participants must have high volume disease (as defined by visceral lesion or 4 or greater bone lesions, at least one of which is beyond the spine and pelvis).
  • mCRPC participants:
  • Must need ADT as part of their cancer therapy (unless previous orchiectomy)
  • Must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.
  • Must have not had progression while on docetaxel if given for mCSPC or within 3 months of completing docetaxel for mCSPC.
  • Progression defined as either rising PSA greater than 2.0 ng/ml or radiographic evidence of progression seen on CT scan or TC-99 bone scan.
  • Toxicities related to prior therapy, including surgery and/ or radiation, must have resolved to <= grade 1.
  • Men age >=18 years. Because no dosing or adverse event data are currently available on the use of M9241 in combination with docetaxel in participants <18 years of age, children are excluded from this study.
  • ECOG performance status 0-2.
  • Participants must have adequate organ and marrow function as defined below:
  • Absolute neutrophil count >=1,500/mcL, without CSF support
  • Platelets >=100,000/mcL
  • Hemoglobin >9 g/dL
  • PT <= 1.5 x ULN
  • aPTT <= 1.5 x ULN
  • Total bilirubin <= upper limit of normal (ULN), OR in participants with Gilbert s syndrome, a total bilirubin <= 3.0
  • Serum albumin >=2.8 g/dL
  • AST(SGOT)/ALT(SGPT) <=1.5 X institutional upper limit of normal -- Hepatic function based on Child-Pugh Class: Participants with hepatic impairment must have Child-Pugh Class A or better
  • Serum Creatinine OR Creatinine Clearance <= 1.5 X institutional upper limits of normal OR >=50 mL/min/1.73 m^2 calculated by eGFR in the clinical lab for participants with serum creatinine levels > 1.5 ULN
  • The effects of M9241 in combination with docetaxel and abiraterone on the developing human fetus are unknown. For this reason and because docetaxel agents as well as other immuno-therapeutic agents used in this trial are known to be teratogenic, sexually active subjects and their female partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom)after enrollment on study , during the study treatment and for 4 months after the last dose of abiraterone, docetaxel or M921, even if oral contraceptives are also used. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately and her partner should inform the study doctor immediately.
  • Ability of subject to understand and the willingness to sign a written informed consent document. Subject should be willing to travel to the NIH for follow-up visits.
  • Participants with prior immune checkpoint therapy are eligible to enroll upon PI discretion.

Exclusion Criteria:

  • Immunocompromised status due to:
  • Human immunodeficiency virus (HIV) positivity
  • Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
  • Other immunodeficiency diseases that in the opinion of the investigator could compromise the participants or limit treatment efficacy
  • Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with a participant s ability to carry out the treatment program.
  • Current use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto).
  • Concurrent use of CYP3A4 inducers or sensitive CYP2D6 substrates within 14 days or 5 half-lives, whichever is shorter.
  • Receipt of any investigational agent within 28 days (or 60 days for an antibody drug conjugates) before the first planned dose of study drugs.
  • Participants who are positive for Hepatitis B surface antigen and/or Anti-Hepatitis C antibody
  • Uncontrolled hypertension (SBP>170/ DBP>105)
  • Has received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.
  • Participants who have had prior docetaxel for mCRPC
  • mCSPC participants will be excluded if they did not start abiraterone within 6 weeks of ADT and/or had any docetaxel
  • Participants who have had progression within 3 months of completing docetaxel for mCSPC
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to M9241 investigational agents used in the study
  • The subject has had evidence within 3 years of the start of study treatment of another active malignancy which required systemic treatment (except for nonmelanoma skin cancers or carcinoma in situ of the bladder).
  • The subject has active brain metastases or epidural disease.
  • Participants with greater than or equal to grade 2 peripheral neuropathy (defined by CTCAE 5.0) at baseline.

View trial on ClinicalTrials.gov


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Multiple-Arm Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb20717 in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer


Condition: Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05733351

Sponsor: Emory University

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Age >= 18 years
  • Histologically confirmed adenocarcinoma of the prostate with metastatic disease
  • Castration-sensitive status: either not have been treated with androgen deprivation therapy (ADT) (hormone therapy) or not on ADT at the time of progression
  • Participants can have received up to 3 months of ADT with luteinizing hormone-releasing hormone (LHRH) agonists or antagonists or orchiectomy with or without concurrent first-generation antiandrogens prior to enrollment, with no radiographic evidence of disease progression or rising prostate-specific antigen (PSA) prior to enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy > 12 weeks as determined by the investigator
  • Hemoglobin >= 9.0 g/dl (within 28 days of cycle 1 day 1) (no transfusions allowed within 7 days of Cycle 1 Day 1 to meet entry criteria)
  • White blood cell (WBC) >= 2000/uL (within 28 days of cycle 1 day 1) (after at least 7 days without growth factor support or transfusion)
  • Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days of cycle 1 day 1) (after at least 7 days without growth factor support or transfusion)
  • Platelets >= 100,000/mcL (within 28 days of cycle 1 day 1) (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria)
  • Prothrombin time (PT)/ partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
  • Total bilirubin =< 1.5 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 3 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
  • Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28 days of cycle 1 day 1)
  • Willingness to provide pre- and post-treatment fresh tumor biopsies, if safe and medically feasible
  • Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of Xmab27017
  • Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol specified laboratory tests, other study procedures, and study restrictions
  • Completion of all previous surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy for the treatment of cancer >= 2 weeks before the start of study therapy. (No radiotherapy to Xmab27017 injection site within 4 weeks)
  • Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1)
  • Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
  • Prior treatment with any CTLA4, PD1, or PDL1, or directed immunotherapy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to (investigational new drug [IND] agent[s]) or other agents used in study
  • Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), are clinically stable, and are without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
  • Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
  • Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted.)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Receipt of an organ allograft
  • Known history of left ventricular ejection fraction =< 40%
  • Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted. COVID-19 vaccines are permitted)
  • Known human immunodeficiency virus (HIV) positive subject with CD4+ T-cell (CD4+) counts < 350 cells/uL, or an HIV viral load greater than 400 copies/mL, or a history of an AIDS (acquired immunodeficiency syndrome)-defining opportunistic infection within the past 12 months, or who has not been on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of study drug dosing. (Effective ART is defined as a drug, dosage, and schedule associated with reduction and control of the viral load.)
  • Known positive test for hepatitis C ribonucleic acid (RNA) (a subject who is hepatitis C virus [HCV] antibody positive but HCV RNA negative due to documented, curative prior antiviral treatment or natural resolution is eligible).
  • Known positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb; a subject whose HBsAg is negative and HBcAb is positive may be enrolled if a hepatitis B virus [HBV] deoxyribonucleic acid (DNA) test is negative, and the subject is retested for HBsAg and HBV DNA every 2 months)

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Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04946370

Sponsor: Weill Medical College of Cornell University

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: Male

Inclusion Criteria:

  • Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate adenocarcinoma.
  • A male participant must agree to use a contraception during the treatment period and for at least 4 months after the last dose of study treatment and refrain from donating sperm during this period.
  • Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: PSA progression, Objective radiographic progression in soft tissue, New bone lesions
  • ECOG performance status of 0-1
  • Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy.
  • Have previously been treated with at least one of the following in any disease state: Androgen receptor signaling inhibitor (such as enzalutamide), CYP 17 inhibitor (such as abiraterone acetate). These drugs may have been initiated in the metastatic hormone sensitive or non-metastatic (M0) CRPC setting provided they meet criteria for progressive mCRPC at study entry.
  • Age > 18 years
  • Patients must have normal organ and marrow function as defined: Absolute neutrophil count >2,000 cells/mm3, Hemoglobin ≥9 g/dL, Platelet count >150 x 10^3/mcL, Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal), Serum AST and ALT <3 x ULN in absence of liver metastases; < 5x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria), Serum internalized normalized ratio (INR) OR prothrombin time (PT) AND activated partial thromboplastin time (aPTT) must be <1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior receipt of chemotherapy for castration-resistant prostate cancer. Prior receipt of docetaxel chemotherapy in the hormone sensitive setting or for localized disease is acceptable provided at least 6 months has passed since the last dose.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Prior bone-seeking beta-emitting radioisotopes (e.g. Sm-153, Sr-89) or investigational PSMA-targeted therapy; prior radium-223 is allowed provided last dose administered >12 weeks prior to C1D1 on this study
  • Has a history of a second malignancy, unless treatment with curative intent has been completed with no evidence of malignancy for 2 years. Patients with treated localized non-melanoma skin care, non-muscle invasive urothelial carcinoma, or carcinoma in-situ of other site are not excluded.
  • Known history of myelodysplastic syndrome
  • Has a known history of Human Immunodeficiency Virus (HIV) infection
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or <5 half-lives prior to enrollment.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • Diagnosis of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Has received radiotherapy within 4 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Patients on stable dose of bisphosphonates or denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study. These drugs may be added after week 12.
  • Unless azoospermia is present (whether due to surgery or underlying medical condition), having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principal investigator and chairperson during the study and for 4 months after last study drug administration.
  • Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
  • Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines are allowed.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy at the time of treatment initiation
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Has had an allogenic tissue/solid organ transplant

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Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer, mCRPC

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05340374

Sponsor: Peter MacCallum Cancer Centre, Australia

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Male patients aged 18 years or older at the time of informed consent.
  2. Patient has provided written informed consent.
  3. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  5. Patients must have had prior treatment with docetaxel.
  6. Patients must have progressed on a second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, or apalutamide) in the castrate-resistant setting.
  7. Patients must have progressive disease. The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) defines this as any one of the following:
  8. PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement
  9. Soft tissue or visceral disease progression as per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria
  10. Bone progression: ≥ 2 new lesions on bone scan
  11. At least three weeks since the completion of surgery prior to registration.
  12. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist).
  13. Serum testosterone levels ≤ 1.75nmol/L within 28 days prior to registration.
  14. Imaging evidence of metastatic disease documented with either whole body bone scan (WBBS) or computed tomography (CT) scan performed within 28 days prior to registration.
  15. Significant prostate-specific membrane antigen (PSMA) avidity on PSMA PET/CT, defined as a minimum uptake of SUVmax 15 at a site of disease.
  16. Patients must have a life expectancy ≥ 12 weeks.
  17. Assessed by a medical oncologist as suitable for treatment with cabazitaxel and 177Lu-PSMA-6
  18. Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:
  19. Haemoglobin ≥ 90 g/L independent of transfusions (no red blood cell transfusion in last 28 days prior to registration)
  20. Absolute neutrophil count (ANC) ≥ 1.5x10^9/L
  21. Platelets ≥ 150 x10^9/L
  22. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome, where this applies for the unconjugated bilirubin component
  23. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases
  24. Albumin ≥ 25 g/L
  25. Adequate renal function: patients must have a creatinine clearance estimated of ≥ 40 mL/min using the Cockcroft-Gault equation
  26. Sexually active patients are willing to use medically acceptable forms of barrier contraception.
  27. Willing and able to comply with all study requirements, including all treatments and the timing and nature of all required assessments.

Exclusion Criteria:

  1. Superscan on WBBS or diffuse marrow disease on PSMA PET.
  2. Site(s) of measurable disease that are FDG-positive with low PSMA expression (SUVmax <10).
  3. Prior treatment with cabazitaxel or 177Lu-PSMA-6
  4. Contraindications to the use of corticosteroid treatment.
  5. Other malignancies within the previous 2-years other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.
  6. Presence of untreated brain metastases or leptomeningeal metastases.
  7. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ four weeks.
  8. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
  9. Persistent toxicities (CTCAE v5.0 >/= Grade 2) caused by previous cancer therapy, excluding alopecia.
  10. Known HIV or hepatitis B or C infection.
  11. Radiotherapy or systemic anti-cancer therapies administered within 14 days prior to registration, excluding androgen deprivation therapy (ADT).

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Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer, mCRPC, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05383079

Sponsor: Peter MacCallum Cancer Centre, Australia

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patient must be ≥ 18 years of age and must have provided written informed consent.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate, OR unequivocal diagnosis of metastatic prostate cancer. (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) with an elevated serum PSA.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Patients must have progressed on ≥ 1 second-generation AR-targeted agent (e.g., enzalutamide, abiraterone, apalutamide, or darolutamide).
  • Patients must have progressive disease for study entry. PCWG3 defines this as any one of the following:
  • PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement.
  • Soft tissue progression as per RECIST 1.1 criteria
  • Bone progression: ≥ 2 new lesions on bone scan
  • Symptomatic progression eg. Bone pain
  • At least three weeks since receiving anti-cancer treatment (other than ADT), the completion of surgery or radiotherapy prior to registration.
  • Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist).
  • Serum testosterone levels ≤ 1.75nmol/L (≤ 50ng/dL) within 28 days before registration.
  • Significant PSMA avidity on PSMA PET/CT, defined as a minimum uptake of SUVmax 20 at a site of disease, and SUVmax >10 at sites of measurable disease >10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact).
  • ≥ 2 bone metastases must be present on bone scintigraphy which have not been previously treated with radiotherapy.
  • No contraindication to treatment with a bone antiresorptive agent such as denosumab or zoledronic acid.
  • Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:
  • Haemoglobin ≥ 90 g/L independent of transfusions (no red blood cell transfusion in last four weeks)
  • Absolute neutrophil count ≥ 1.5x10^9/L
  • Platelets ≥ 150 x10^9/L
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome, where this applies for the unconjugated bilirubin component.
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases
  • Albumin ≥ 25 g/L
  • Adequate renal function: patients must have a creatinine clearance estimated of ≥ 40 mL/min using the Cockcroft Gault equation
  • Sexually active patients are willing to use medically acceptable forms of barrier contraception.
  • Willing to undergo biopsies, if disease is considered accessible and biopsy is feasible.
  • Willing and able to comply with all study requirements, including all treatments and the timing and nature of all required assessments.

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded from study entry:
  • Superscan on Bone scan (WBBS) or diffuse marrow involvement on PSMA PET/CT
  • Prior treatment with 223Ra or 177Lu-PSMA.
  • Has received more than one previous line of chemotherapy for the treatment of metastatic prostate cancer.
  • Sites of discordant FDG-positive disease defined by minimal PSMA-expression and no uptake on WBBS (for bone metastases).
  • Other malignancies within the previous 2 years other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.
  • Symptomatic brain metastases or leptomeningeal metastases.
  • Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ four weeks.
  • Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.

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A 2-stage, Lead-in and Randomized, Phase 2, Open-label Study of Darolutamide Versus Enzalutamide as Monotherapy on Testosterone Levels Change in Men With Hormone-Naïve Prostate Cancer


Condition: Biochemically Recurrent Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05526248

Sponsor: Bayer

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Male of ≥ 18 years of age.
  • Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Prior treatment with primary radical prostatectomy or definitive RT for localized prostate cancer
  • Patients must have PSA ≥0.2 ng/mL after ART or SRT post-RP or after RP in participants who are unfit for ART or SRT, OR PSA ≥2 ng/mL above the nadir after primary RT only. (RP, radical prostatectomy; ART, adjuvant radiotherapy; SRT, salvage radiotherapy; RT primary radiotherapy)
  • The presence of < 5 asymptomatic metastatic lesions on conventional or PSMA-PET based imaging methods permitted. Lesions that need treatment with any opioid based analgetic are considered symptomatic
  • PSADT ≤ 20 months calculated per PCWG3 + RECIST 1.1 per Scher et al. (Scher et al. 2016) and MSKCC nomogram.
  • Eastern Cooperative Oncology Group ECOG (PS) of 0
  • 1.
  • Serum testosterone >150 ng/dl.
  • Patients must have adequate organ function within 4 weeks before the first dose of study intervention.
  • More than 30 days (or 5 half-lives) (whichever is longer) since prior participation in another clinical trial with an investigational medicinal product.

Exclusion Criteria:

  • Prior treatment with ADT of up to 6 months for localized disease is permitted but not if during the prior 6 months before first dose of study intervention. Plan to initiate ADT during the trial period is not allowed.
  • Radiation therapy or major surgery within 4 weeks of screening.
  • Systemic glucocorticoids within 3 months prior to the first dose or study intervention was expected to require systemic glucocorticoids during the study period
  • Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
  • Uncontrolled hypertension
  • A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study intervention.
  • Prior history of a clinically significant malignancy with the exception of basal cell, squamous cell carcinoma of the skin, and superficial bladder cancer.
  • Prior treatment with:
  • Second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, darolutamide other investigational AR inhibitors
  • or Cytochrome P17 enzyme inhibitor such as abiraterone acetate as antineoplastic treatment for prostate cancer
  • Prior history of gynecomastia
  • Use of herbal products that may have had hormonal anti-prostate cancer activity or were known to decrease PSA levels (e.g., saw palmetto) within 4 weeks before the first dose of study intervention

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A Phase 1/2 Study of EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With Metastatic Castration-Resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05075577

Sponsor: ESSA Pharmaceuticals

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Males ≥18 years.
  • Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma.
  • Evidence of castration-resistant prostate cancer (CRPC).
  • Presence of metastatic disease at study entry documented by 1 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
  • Naïve to second generation anti-androgens.
  • Evidence of progressive disease defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Ongoing ADT with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy or history of bilateral orchiectomy, with castrate level testosterone.
  • Serum testosterone ≤1.73 nmol/L (50 ng/dL).
  • Subjects receiving bisphosphonates or other approved bone-targeting therapy (e.g., denosumab) must be on a stable dose for at least 28 days prior to the start of study treatment.
  • Demonstrate adequate organ function.

Exclusion Criteria:

  • Biologic anti-cancer therapy within 28 days prior to the start of study treatment.
  • Use of hormonal agents with anti-tumor activity against prostate cancer within 28 days prior to the start of study treatment.
  • Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity within 28 days prior to the start of study treatment or plans to initiate during the study.
  • Intervention with any chemotherapy, investigational agents, or other anti-cancer drugs within 28 days of the first dose of study treatment.
  • Use of radium-223 dichloride or other radioligand/radiopharmaceutical within 28 days prior to the start of study treatment.
  • Received limited-field palliative bone radiotherapy >5 fractions and/or any radiotherapy within 2 weeks prior to the start of study treatment.
  • Received a blood transfusion within 28 days of hematologic screening labs.
  • Known intra-cerebral disease or brain metastasis unless adequately treated and stable for the last 28 days before signing of informed consent.
  • Spinal cord compression.
  • Diagnosis of another clinically significant malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or non-invasive malignancies.
  • Gastrointestinal issues affecting absorption.
  • Significant cardiovascular disease.
  • Known history of seizure or conditions that may pre-dispose them to seizure, including brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, and brain arteriovenous malformation.
  • Concurrent disease or any clinically significant abnormality.
  • Known or suspected hypersensitivity to any components of the formulation used for EPI-7386 or enzalutamide.
  • Use of strong inhibitors of CYP2C8.
  • Use of strong inducers of CYP3A.
  • Use of narrow therapeutic index sensitive CYP2C8 or sensitive substrates for CYP3A and CYP2B6.
  • Use of granulocyte colony stimulating factor within 7 days prior to screening laboratories.
  • Not a candidate for enzalutamide treatment.
  • Patients with rare hereditary problems of fructose intolerance.

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A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-7386 in Patients With Castration-Resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04421222

Sponsor: ESSA Pharmaceuticals

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Male 18 years of age or older.
  • Histologically, pathologically, or cytologically confirmed prostate cancer without small cell features.
  • Evidence of castration-resistant prostate cancer (CRPC).
  • Presence of metastatic disease at study entry documented by 1 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
  • Limited further treatment options available known to confer clinical benefit in this disease setting from the perspective of the treating physician. Specifically, patients must have progressed on at least 2, but not more than 3, prior approved systemic therapies for mCRPC which include at least one, but not more than 2, second generation anti-androgen drug.
  • Patients may have received prior docetaxel for mCSPC or mCRPC but must not have had disease progression during, or within 6 months of completing chemotherapy. Only one line of prior chemotherapy is allowed.
  • Evidence of progressive disease defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria.
  • The patient must have recovered from toxicities related to any prior treatments.
  • Castrate at screening.
  • Patients receiving bisphosphonates or other approved bone-targeting therapy must be on a stable dose for at least 4 weeks prior to the start of study drug.
  • Demonstrate adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Part A/Phase 1b (Dose Expansion) Inclusion Criteria: The inclusion criteria for this cohort are the same as for Phase 1a with the exception of: limit of prior therapies to 2 and prior chemotherapy is not allowed for this cohort of patients. Part B/Cohort 1 (EPI-7386 in combination with AAP) Inclusion Criteria:
  • Patients are eligible to enroll in this cohort if they meet the clinical criteria for receiving AAP as standard of care treatment as per label (i.e., high-risk mHSPC or mCRPC).
  • All other inclusion criteria listed for Part A/Phase 1a apply except for those that do not apply to mHSPC or mCRPC patients (i.e. evidence of CRPC and limited treatment options for mCRPC). Part B/Cohort 2 (Window of Opportunity with clinical endpoints followed by combination with Apalutamide)
  • Male 18 years of age or older.
  • Histologically, pathologically, or cytologically confirmed prostate cancer without small cell features.
  • Evidence of castration-resistant prostate cancer (CRPC).
  • Patients who received a first generation anti-androgen as part of an initial combined androgen blockade therapy or as second-line hormonal therapy must show continuing disease (PSA) progression off the anti-androgen for at least 4 weeks prior to enrollment.
  • At least 4 weeks must have elapsed from the use of 5-α reductase inhibitors, estrogens, and any other anti-cancer therapy prior to enrollment.
  • At least 4 weeks must have elapsed from major surgery or radiation therapy prior to enrollment.
  • The patient must have recovered from toxicities related to any prior treatments.
  • Castrate at screening.
  • Demonstrate adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Part A Phase 1a and Phase 1b Exclusion Criteria:
  • Biologic anti-cancer therapy or a cytotoxic chemotherapy within 4 weeks prior to the start of study drug.
  • Use of hormonal agents with anti-tumor activity against prostate cancer within 4 weeks prior to the start of study drug.
  • Any lutamides or abiraterone within 14 days or 5 half-lives, whichever is longer prior to start of study drug.
  • Use of radium-223 dichloride or other radioligand/radiopharmaceutical within 28 days prior to the start of study drug.
  • Received limited-field palliative bone radiotherapy >5 fractions and/or any radiotherapy within 2 weeks prior to the start of study drug.
  • Received a blood transfusion within 28 days of screening.
  • Received prior chemotherapy (for Part 1b Cohort A only).
  • Known intra-cerebral disease or brain metastasis unless adequately treated and stable for the last 4 weeks before enrollment.
  • Spinal cord compression.
  • Diagnosis of another invasive malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma.
  • Gastrointestinal disorder affecting absorption.
  • Significant cardiovascular disease.
  • Concurrent disease or any clinically significant abnormality.
  • Use of strong inducers of CYP3A within 14 days of the first dose of study drug. Part A Phase 1b (Dose Expansion) Exclusion Criteria: The exclusion criteria for this cohort are the same as the criteria from Phase 1a with the addition of the following: • Any prior treatment with chemotherapy. Part B Cohort 1 (EPI-7386 in combination with AAP) Exclusion Criteria: The

Exclusion Criteria:

  • Biologic anti-cancer therapy or a cytotoxic chemotherapy within 4 weeks prior to the start of study drug.
  • Use of hormonal agents with anti-tumor activity against prostate cancer within 4 weeks prior to the start of study drug.
  • Any lutamides or abiraterone within 14 days or 5 half-lives, whichever is longer prior to start of study drug.
  • Use of radium-223 dichloride or other radioligand/radiopharmaceutical within 28 days prior to the start of study drug.
  • Received limited-field palliative bone radiotherapy >5 fractions and/or any radiotherapy within 2 weeks prior to the start of study drug.
  • Received a blood transfusion within 28 days of screening.
  • Received prior chemotherapy (for Part 1b Cohort A only).
  • Known intra-cerebral disease or brain metastasis unless adequately treated and stable for the last 4 weeks before enrollment.
  • Spinal cord compression.
  • Diagnosis of another invasive malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma.
  • Gastrointestinal disorder affecting absorption.
  • Significant cardiovascular disease.
  • Concurrent disease or any clinically significant abnormality.
  • Use of strong inducers of CYP3A within 14 days of the first dose of study drug. Part A Phase 1b (Dose Expansion) Exclusion Criteria: The exclusion criteria for this cohort are the same as the criteria from Phase 1a with the addition of the following: • Any prior treatment with chemotherapy. Part B Cohort 1 (EPI-7386 in combination with AAP) Exclusion Criteria: The exclusion criteria for this cohort are the same as the criteria from Phase 1a with the addition of the following:
  • Use of concomitant CYP2D6 substrates with narrow therapeutic index.
  • Known allergies, hypersensitivity, or intolerance to the excipients of AA (refer to AA Investigator's Brochure [IB] or package inserts as appropriate). Part B Cohort 2 (Window of Opportunity with clinical endpoints followed by combination with Apalutamide)
  • Presence of distant metastases, including visceral, nodal and bones involvement. Exception: pelvic lymph nodes < 2 cm in short axis (N1) located below the iliac bifurcation are allowed.
  • Symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis due to primary tumor.
  • Prior treatment with second generation anti-androgens.
  • Prior treatment with CYP17 inhibitors.
  • Prior treatment with radiopharmaceutical agents, immunotherapy, or any other investigational agent for nmCRPC.
  • Prior chemotherapy.
  • History or evidence of: prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 3 years prior to enrollment; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events; uncontrolled hypertension.
  • Gastrointestinal disorder affecting absorption.
  • Use of strong inducers of CYP3A within 14 days of the first dose of study drug.

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AcTION: A Phase I Study of [225Ac]Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer With or Without Prior [177Lu]Lu-PSMA-617 Radioligand Therapy


Condition: Prostatic Neoplasms, Castration-Resistant

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04597411

Sponsor: Endocyte

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patients must have the ability to understand and sign an approved ICF.
  • Patients must have the ability to understand and comply with all protocol requirements.
  • Patients must be >=18 years of age.
  • Patients must have an ECOG performance status of 0 to 2.
  • Patients must have had histological, pathological, and/or cytological confirmation of prostate cancer.
  • Patients must have a positive 68Ga-PSMA-11 PET/CT scan performed within 28 days of study entry as described in Imaging Manual).
  • Patients must have recovered or stabilized to =< Grade 2 or baseline from all clinically significant toxicities related to prior prostate cancer therapy.
  • Determination of disease progression on treatment prior to enrollment. Progressive disease for study entry is defined as any one or more of the following: 1. PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of >= 1 week between each measurement. 2.0 ng/mL is the minimal starting value if PSA rise is only indication of progression. 2. Soft tissue or visceral disease progression as per RECIST 1.1 criteria: increase >= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions. 3. Bone progression: >= 2 new lesions on bone scan.
  • Patients must have adequate organ function (bone morrow reserve, hepatic function and renal function).
  • Known HIV-positive patients who are healthy and have a low risk of AIDS-related outcomes are eligible. HIV testing is required.
  • For patients who have partners of childbearing potential, patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.
  • Group A Subjects: Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy, a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L) and must have received prior cytotoxic chemotherapy and a novel androgen axis drug (e.g., abiraterone or enzalutamide). Patients must also be naïve to prior 177Lu-PSMA radioligand therapy (177Lu-PSMA-617 or 177Lu-PSMA I&T)
  • Group B Subjects (South-Africa only): Patients must have ongoing androgen deprivation therapy (ADT) and either prior orchiectomy or be medically castrate using LHRH agonists/antagonists in order to achieve adequate suppression of serum testosterone (< 50 ng/dL) but must not have received prior cytotoxic chemotherapy or novel androgen axis drugs (e.g., abiraterone or enzalutamide). These patients are naïve to 177Lu-PSMA radioligand therapy (177Lu-PSMA-617 or 177Lu-PSMA I&T).
  • Group C Subjects: Patients must have ongoing androgen deprivation therapy (ADT) and either prior orchiectomy or be medically castrate using LHRH agonists/antagonists in order to achieve adequate suppression of serum testosterone (< 50 ng/dL). Patients must have been treated with prior 177Lu-PSMA radioligand therapy (177Lu-PSMA-617 or 177Lu-PSMA I&T) for at least one cycle administered greater than 6 weeks from study enrollment, and been evaluated for biochemical and radiological response to therapy. Prior exposure to ARPI and/or chemotherapy is not required.

Exclusion Criteria:

  • Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.
  • Any investigational agents within 28 days of study enrollment.
  • Known hypersensitivity to the components of the study therapy or its analogues.
  • Other concurrent cytotoxic chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy, or investigational therapy.
  • Transfusion for the sole purpose of eligibility into the study.
  • Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with a prior history of malignancy who have been disease free for more than 3 years are eligible.
  • Participants with an active documented COVID-19 infection (any grade of disease severity) at the time of informed consent may be included only when completely recovered (in accordance with local guidance).

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SatisfACtion: A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With Heavily Pre-treated PSMA Positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy.


Condition: Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05983198

Sponsor: Novartis Pharmaceuticals

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Key Inclusion Criteria:

  • Evidence of PSMA-positive disease by 68Ga-PSMA-R2 PET/CT and eligible as determined by central reading
  • Documented progressive mCRPC
  • Adequate organ function (bone marrow reserve, hepatic, renal)
  • Prior orchiectomy and/or ongoing ARPI and taxane-based chemotherapy and should have received prior 177Lu-PSMA-RLT (Group1 dose escalation & expansion) or never received 177Lu-PSMA-RLT (Group 2 dose escalation & expansion).

Key Exclusion Criteria:

  • Any other investigational agents within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy
  • Any systemic anti-cancer therapy within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy
  • Uncontrolled pain or incompatibility that may result in participant's lack of ability to comply with imaging procedures
  • History of CNS metastases and symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
  • Uncontrolled cardiovascular history
  • Diagnosis of other malignancies expected to alter life expectancy or may interfere with disease assessment Other protocol-defined inclusion/

Exclusion Criteria:

  1. may apply.

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A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05803941

Sponsor: Novartis Pharmaceuticals

Phase: Phase 4

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation in the study
  2. Must have received at least one dose of AAA617 within an interventional, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.
  3. Willingness of sexually active participant to use a condom during intercourse for up to 14 weeks from the last dose of AAA617 treatment administered on the parent study.

Exclusion Criteria:

  1. Inability to complete the needed investigational examinations due to any reason.

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A Prospective, Open-label, Multi-center, Single-arm, Phase II Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Condition: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05670106

Sponsor: Novartis Pharmaceuticals

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Written informed consent must be obtained before any assessment is performed. 2. Participants must be Chinese male adults >= 18 years of age. 3. Participants must have histological, pathological, and/or cytological confirmation of prostate cancer. 4. Participants must be [68Ga]Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader according to the VISION read rules. 5. Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dl, or < 1.7 nmol/L). 6. Participants must have received at least one ARPI (such as enzalutamide and/orabiraterone). 7. Participants must have been previously treated with at least 1, but no more than 2 previous taxane regimens.
  • A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane regimen, the participant is eligible if: the participants' physician deems him unsuitable to receive a second taxane regimen (e.g., frailty assessed by geriatric or health status evaluation or intolerance, etc.) 8. Documented progressive mCRPC, based on at least 1 of the following criteria:
  • Serum/plasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week apart, the minimal start value is 2.0 ng/ml
  • Soft-tissue progression defined based on PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)
  • Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016) 9. Participants must have >= 1 metastatic lesion that is present on baseline CT, MRI or bone scan imaging obtained =< 21 days prior to enrollment via central reading.
  • In main part: participant must have at least one measurable lesion by PCWG3-modified RECIST v1.1 via central reading 10. Participants must have adequate organ function:
  • Bone marrow reserve:
  • White blood cell (WBC) count >= 2.5 × 109/L OR absolute neutrophil count (ANC) >= 1.5 × 109/L
  • Platelets >=100 × 109/L
  • Hemoglobin >= 9 g/dL
  • Hepatic:
  • Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =< 3 × ULN is permitted
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 3.0 × ULN OR =< 5.0 × ULN for participants with liver metastases
  • Renal:
  • eGFR >= 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation 11. Albumin >3.0 g/dL.

Exclusion Criteria:

  • 1. Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation. 2. Previous PSMA-targeted radioligand therapy. 3. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies], APRI is not included) within 28 days prior to day of enrollment. 4. Any investigational agents (e.g. poly adenosine diphosphate-ribosyl polymerase inhibitors [PARPi]) within 28 days prior to day of enrollment. 5. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes. 6. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 7. Transfusion for the sole purpose of making a subject eligible for study inclusion. 8. Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
  • Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids.
  • Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. 9. Symptomatic spinal cord compression, or clinical or radiologic findings indicative of impending cord compression.

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An Open-label, Multi-center, Randomized, Phase II Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer


Condition: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05658003

Sponsor: Novartis Pharmaceuticals

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Key Inclusion Criteria:

  • 1. Participants must be Chinese adult men >= 18 years of age 2. Participants must have an ECOG performance status of 0 to 1 3. Participant must have histological pathological and/or cytological confirmation of adenocarcinoma of the prostate 4. Participants must be [68Ga]Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader 5. Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dl, or < 1.7 nmol/L) 6. Participants must have progressed only once on prior second generation ARDT (abiraterone, enzalutamide, darolutamide, or apalutamide)) in either HSPC or CRPC setting.
  • first generation androgen receptor inhibitor therapy (e.g. bicalutamide) is allowed but not considered as prior ARDT therapy
  • second generation ARDT must be the most recent therapy received 7. candidates for change in ARDT (eligible to receive abiraterone or enzalutamide) as assessed by the treating physician • Participants cannot have previously progressed nor had intolerable toxicity to both enzalutamide and abiraterone 8. Documented progressive mCRPC, based on at least 1 of the following criteria:
  • Serum/plasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week apart. the minimal start value is 2.0 ng/ml;
  • Soft-tissue progression defined based on PCWG3-modified RECIST v1.1(Eisenhauer et al 2009, Scher et al 2016)
  • Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria Scher et al 2016) 9. Participants must have at least one metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained =< 28 days prior to randomization 10. Participants must have adequate organ function:
  • Bone marrow reserve:
  • ANC >= 1.5 x 109/L
  • Platelets >= 100 x 109/L
  • Hemoglobin >= 9 g/dL
  • Hepatic:
  • Total bilirubin < 2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =< 3 x ULN is permitted
  • ALT or AST =< 3.0 x ULN OR =< 5.0 x ULN for participants with liver metastases
  • Albumin >= 2.5 g/dL
  • Renal:
  • eGFR >= 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation

Key Exclusion Criteria:

  • 1. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutitium-177, Actium-225, hemi-body irradiation 2. Previous PSMA-targeted radioligand therapy 3. Prior treatment with PARP inhibitor, cytotoxic chemotherapy for castration resistant or castration sensitive prostate cancer (i.e., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy (including monoclonal antibodies). [Note: a maximum of 6 cycles of taxane exposure in the adjuvant or neo-adjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neo-adjuvant therapy prior to randomization] 4. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy 5. Transfusion or use of bone marrow stimulating agents for the sole purpose of making a participant eligible for study inclusion 6. Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
  • Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids.
  • Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. 7. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression 8. Cardiac or cardiac repolarization abnormality, including any of the following:
  • History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
  • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block) and QTc>=500. 9. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation 10. Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: Participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed.

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An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies


Condition: Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04464226

Sponsor: Bayer

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
  • Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
  • Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion Criteria:

  • Participant is unable to comply with the requirements of the study.
  • Negative benefit/ risk ratio as determined by the investigator.
  • Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.

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A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH


Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04597125

Sponsor: Bayer

Phase: Phase 4

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Participants who have histologically confirmed adenocarcinoma of the prostate.
  • Participants with mCRPC progressing on/after one line of an approved NAH (eg. abiraterone, enzalutamide, apalutamide, or darolutamide, after being treated for at least 3 months) in an authorized prostate cancer indication.
  • One prior taxane treatment regimen (at least 2 cycles) for metastatic prostate cancer (mHSPC and mCRPC) or refusal or ineligibility of such a regimen.
  • Prostate cancer progression documented by PSA according to the Prostate Cancer Working Group 3 (PCWG3) criteria or radiological progression according to RECIST, version 1.1.
  • At least 2 bone metastases on bone scan within 4 weeks prior to randomization with no current or history of lung, liver, other visceral, and / or brain metastasis.
  • Symptomatic prostate cancer. A worst pain score (WPS) of at least 1 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours). This is to be assessed once during the Screening period.
  • Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study.
  • Participants must be on a BHA treatment, such as bisphosphonates or denosumab treatment unless such treatment is contraindicated or not recommended per investigator's judgement and inclusion is agreed to by the medical monitor.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
  • Life expectancy ≥ 6 months.
  • Able to swallow abiraterone and prednisone/prednisolone or enzalutamide as whole tablets/capsules.
  • Laboratory requirements:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L; 5.6 mmol/L)
  • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (except for participants with documented Gilbert's disease)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 as calculated using the Cockcroft-Gault equation
  • International normalized ratio (INR) of prothrombin time (PT; PT-INR) and partial thromboplastin time (PTT) ≤ 1.5 times the ULN. Participants treated with warfarin or heparin will be allowed to participate in the study if no underlying abnormality in coagulation parameters exists per prior history; weekly evaluation of PT-INR / PTT will be required until stability is achieved (as defined by local standard of care and based on pre-study PT-INR / PTT values)
  • Serum albumin > 30 g/L
  • Serum potassium ≥ 3.5 mmol/L
  • Capable of giving signed informed consent

Exclusion Criteria:

  • Active infection or other medical condition that would make prednisone / prednisolone (corticosteroid) use contraindicated.
  • Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone / prednisolone equivalent daily for more than 2 months.
  • Pathological finding consistent with tumors with predominant neuroendocrine features or small cell carcinoma of the prostate.
  • History of osteoporotic fracture
  • History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations.
  • History of or known brain metastasis.
  • Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
  • Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
  • Imminent spinal cord compression based on clinical findings and / or magnetic resonance imaging (MRI). Participants with history of spinal cord compression should have completely recovered.
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  • Active or symptomatic viral hepatitis
  • History of pituitary or adrenal dysfunction
  • Any other serious illness or medical condition such as, but not limited to:
  • Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 2
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II to IV heart disease or cardiac ejection fraction measurement of <50% at baseline
  • Current clinical evidence of any uncontrolled cardiac arrhythmia
  • Crohn's disease or ulcerative colitis
  • Bone marrow dysplasia
  • Moderate and severe hepatic impairment (Child-Pugh Classes B and C)
  • Unmanageable fecal incontinence.
  • Any condition, which in the opinion of the investigator would preclude participation in this trial (eg, history of seizure).
  • Hypersensitivity to the active substances or to any excipients of radium-223 dichloride, or abiraterone acetate or enzalutamide.
  • Prior therapeutic systemic radiation with any radiopharmaceutical medication for the treatment of prostate cancer, including but not limited to lutetium-177, strontium-89, samarium-153, iodine-131, rhenium-186, rhenium-188, or radium-223. Radiopharmaceutical compounds used for diagnosis purposes only are allowed.
  • Prior hemibody external radiotherapy is excluded. Participants who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for Hb, ANC, and platelet count.
  • Blood transfusion or erythropoietin stimulating agents 4 weeks prior to Screening and during the whole Screening period before randomization.
  • Excessive intake of biotin above the recommended daily dose of 30 μg. Biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth at levels that may interfere with laboratory tests.
  • Prior administration of an investigational therapeutic for CRPC.
  • Previous (within the last 4 weeks of randomization) or concurrent participation in any interventional clinical study with investigational study drug administration.

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A Single-arm, Open-label Phase 4 Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy for Participants in India With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)


Condition: Non-metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05348876

Sponsor: Bayer

Phase: Phase 4

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Capable of giving signed informed consent.
  • Participant must be male aged ≥ 18 years.
  • Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
  • Castration resistance, demonstrated by:
  • a minimum of 3 rising PSA values while the participant is on continuous ADT (started at least 4 weeks prior to the PSA measurement or, PSA measured at least 4 weeks after bilateral orchiectomy) and
  • the interval between each PSA measurement must be ≥ 1 week, and
  • the PSA value at screening must be ≥ 1.0 ng/mL (1.0 μg/L). To confirm this eligibility criterion, it is acceptable for 2 out of the 3 PSA measurements to be taken during the 28-day screening period (after participant has signed consent), provided the measurements are ≥ 1 week apart. In this case, the last PSA value should be recorded as the screening value.
  • Castrate level of serum testosterone (< 1.7 nmol/L [50 ng/dL]) on gonadotropin releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy. Participants who have not undergone bilateral orchiectomy must continue GnRH therapy during the study.
  • PSA doubling time (PSADT) of ≤ 10 months.
  • Eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1.
  • Estimated glomerular filtration rate (eGFR) > 15 mL/min/1.73 m^2.
  • Blood counts at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1500/μL (1.5 × 109/L), platelet count ≥ 100,000/μL (100 ×109/L) (participant must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening).
  • Screening values of serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN), total bilirubin (TBL) ≤ 1.5 × ULN (except participants with a diagnosis of Gilbert's disease), creatinine ≤ 2.0 × ULN.
  • Sexually active participants, unless surgically sterile, must agree to use a male condom plus partner use of a contraceptive method with a failure rate of <1% per year, and refrain from sperm donation during the study treatment and for 1 week after the last dose of study treatment. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  • History of metastatic disease at any time or presence of detectable metastases by investigator assessment within 42 days prior to start of study treatment based on standard medical imaging, i.e., computed tomography/ magnetic resonance imaging (CT/MRI) and bone scan. (Lesions seen on prostate-specific membrane antigen /positron emission tomography (PSMA/PET) scan that are not detected on standard imaging do not exclude participation.) Presence of pelvic lymph nodes < 1.5 cm in short axis below the aortic bifurcation is allowed.
  • Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer.
  • Acute toxicities of prior treatments and procedures not resolved to common terminology criteria for adverse events (CTCAE) v.5.0 grade ≤ 1 or baseline before first dose of study treatment.
  • Severe or uncontrolled concurrent disease, infection, or co-morbidity that, in the opinion of the investigator, would make the participant inappropriate for enrollment.
  • Known hypersensitivity to the study treatment or any of its ingredients.
  • Major surgery within 28 days before first dose of study treatment.
  • Any of the following within 6 months before first dose of study treatment: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association Class III or IV.
  • Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg at screening despite medical management. Participants with hypertension can enroll provided BP is stable and controlled by anti-hypertensive treatment.
  • End-stage renal disease (eGFR < 15 mL/min/1.73 m^2).
  • Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥ 5 years ago and from which the participant has been disease-free.
  • Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
  • Unstable active viral hepatitis with a need for treatment.
  • Known human immunodeficiency virus (HIV) infection with any of the following (Note: HIV testing is not required unless mandated by local authority):
  • CD4+ T-cell (CD4+) count of less than 350 cells/μL
  • History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months
  • On established antiretroviral therapy for less than 4 weeks
  • Presenting with a viral load of more than 400 copies/mL prior to enrollment
  • On antiretroviral therapy or prophylactic antimicrobials that are expected to cause significant drug-drug interactions or overlapping toxicities with study treatment and cannot be changed to alternative agents.
  • Any condition that, in the opinion of the investigator, would impair the participants' ability to comply with the study procedures or study treatment (e.g., unable to swallow study treatment).
  • Unwilling or unable to comply with all protocol-required visits and assessments or comply with study requirements.
  • Prior treatment with:
  • Second-generation androgen receptor (AR) inhibitors (such as enzalutamide, apalutamide, darolutamide, proxalutamide, etc)
  • Other investigational AR inhibitors
  • Cytochrome P450 (CYP17) enzyme inhibitors (such as oral ketoconazole, abiraterone acetate, TAK-700, etc).
  • Use of first-generation AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before first dose of study treatment.
  • Use of estrogens or 5-α reductase inhibitors (finasteride, dutasteride) within 28 days before first dose of study treatment.
  • Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvant treatment completed > 2 years before first dose of study treatment.
  • Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before first dose of study treatment.
  • Radiation therapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 12 weeks before first dose of study treatment.
  • Treatment with an osteoclast-targeted therapy (bisphosphonate or denosumab) to prevent skeletal-related events within 4 weeks before first dose of study treatment. Participants receiving osteoclast-targeted therapy to prevent bone loss at a dose and schedule indicated for osteoporosis may continue treatment at the same dose and schedule.
  • Treatment with any investigational drug within 28 days before first dose of study treatment.

View trial on ClinicalTrials.gov


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