Prostate Cancer

{{header-clinical-trials-navigation}}

Prostate Cancer Biomarker Enrichment and Treatment Selection (PC-BETS) Study


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03385655

Sponsor: Canadian Cancer Trials Group

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • The following will be required prior to REGISTRATION:
  • Patients must have histologically confirmed adenocarcinoma of the prostate without pathologic or clinical evidence (e.g. PSA < 2.0 μg/L with liver metastases) of small cell neuroendocrine differentiation.
  • Patients must consent prior to blood collection for screening correlative testing by a central reference laboratory. The screening blood sample cannot be sent for analysis prior to screening registration.
  • All patients must have consented to the release of a tumour block from their primary or metastatic tumour. The centre/pathologist must have agreed to the submission of the specimen(s). Contact CCTG if no archival tissue is available.
  • Patients must have evidence of castrate resistance with either biochemical or radiological disease progression in the setting of surgical or medical castration: PSA Progression:
  • Minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement
  • PSA must be ≥ 2.0 µg/L (ng/mL) Objective progression:
  • RECIST 1.1, or
  • PCWG3 Criteria for bone progression Surgical/Medical Castration:
  • Prior bilateral orchiectomy, or
  • LHRH agonist/antagonist and testosterone < 50 ng/dL or < 1.7 nmol/L. LHRH agonist/antagonist therapy must be maintained for the duration of study therapy and if previously discontinued, must be restarted and castrate level of testosterone present.
  • Patients must be ≥18 years of age.
  • ECOG performance status 0 or 1 (Appendix I) and have a life expectancy of ≥ 6 months.
  • Patients must have radiologically documented disease (measurable or non-measurable as defined by RECIST 1.1. Patients with elevated PSA only are not eligible.
  • Neutrophils ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Hemoglobin ≥ 90 g/L; contact CCTG if hemoglobin is between 80-89 g/L, patient is not decompensated, is asymptomatic and transfusion is not indicated.
  • Serum potassium within normal limits
  • Bilirubin ≤ 1.5 ULN; if confirmed Gilbert's then bilirubin ≤ 3.0 x ULN
  • ALT ≤ 2.5 x ULN; if patient has liver metastases ≤ 5.0 x ULN
  • Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 45 mL/min; measured directly by 24-hour urine sampling OR as calculated by Cockcroft and Gault equation: Males: GFR = 1.23 x (140-age) x weight in kg/serum creatinine in μmol/L
  • Patient consent for screening and subsequent enrollment (as applicable) must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to screening and subsequent enrollment (as applicable) in the trial to document their willingness to participate. Additional Criteria to be met prior to SUB-STUDY ENROLLMENT:
  • Patients must have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).
  • Prior major surgery is permitted provided that a minimum of 14 days have elapsed between any major surgery and enrollment (7 days for minor surgery e.g. port insertion), and that wound healing has occurred.
  • Prior external beam radiation or radium-223 is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose and enrollment. Consult CCTG if patients have received other therapeutic radioisotopes. Exceptions may be made for low-dose non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiation is not permitted. If radiation is required for example for pain control, it must be completed prior to enrollment. Prior strontium-89 at any time is not permitted.
  • Previous Hormone Therapy: Patients must have received prior hormonal treatment with at least one of: abiraterone acetate, enzalutamide, apalutamide (ARN-509), darolutamide (ODM-201), TAK-700 and TOK-001 or other next-generation AR-pathway inhibitor (if agent is not listed, must be discussed and approved with CCTG prior to registration). Consult substudies for additional criteria
  • Prior cytotoxic therapy: Patients may have received cytotoxic therapy in the castrate sensitive setting as well as up to 1 regimen of cytotoxic therapy in the CRPC setting
  • Patients must have an adequate washout prior to enrollment as follows:
  • Longest of one of the following:
  • Standard cycle length of standard therapies;
  • Two weeks;
  • The longer of 30 days or 5 half-lives for investigational agents;
  • Patients must have discontinued anti-androgens for at least 4 weeks prior to substudy entry/enrollment (at least 6 weeks for bicalutamide).
  • LHRH agonist therapy must continue unless surgically castrated. Note: after discussion, CCTG selected patients may be screened prior to adequate washout.
  • Patient must have progressed (biochemically or radiologically, as defined in 4.1.4) during or after their last systemic therapy
  • Patients must be accessible for treatment and follow up. Patients registered enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
  • Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
  • Patients must agree to return to their primary care facility for any adverse events, which may occur through the course of the trial.
  • In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment.
  • Men of childbearing potential must have agreed to use a highly effective contraceptive method during study drug treatment for 6 months after stopping treatment and should not father a child or donate sperm during this period.
  • In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy / vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he is responsible for beginning contraceptive measures.

Exclusion Criteria:

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 2 years.
  • Patients with central nervous system (CNS) involvement unless at least 4 weeks from prior therapy completion (including radiation and/or surgery) AND clinically stable and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases. Patients with epilepsy not due to CNS metastases are eligible as long as no contraindication or concern with drug interactions.
  • Patients with serious illnesses or medical conditions which could cause unacceptable safety risks or would not permit the patient to be managed according to the protocol. This includes but is not limited to:
  • active infection requiring systemic therapy;
  • active or known human immunodeficiency virus (HIV) with detectable viral load;
  • uncontrolled or recent clinically significant cardiac disease, including:
  • angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months;
  • history of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy;
  • history of any cardiac arrhythmias, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months;
  • patients with uncontrolled hypertension.
  • Patients with significant liver diseases including viral/other hepatitis, current alcohol abuse or cirrhosis.
  • Patients who are unable to swallow oral medication and/or have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, active bowel inflammation (e.g. diverticulitis) or small bowel resection), unless agreed with CCTG (exceptions may be given if parenteral substudy is available/appropriate.
  • Patients who require continued or concurrent treatment with:
  • Systemic corticosteroids at a dose equivalent to prednisone > 10 mg daily. Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are allowed.
  • Bisphosphonates / denosumab for reasons other than hypercalcemia, osteoporosis or prevention of skeletal-related events.
  • Other anti-cancer or investigational agents (except LHRH)
  • History of hypersensitivity to any of the study drugs or any excipient.
  • Patients with a history of non-compliance to medical regimens.
  • Patients who have received growth factors within 28 days prior to initiation of dosing of study drug or who are likely to require treatment with growth factors throughout the duration of the trial.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Randomized Phase II Trial to Evaluate the Antitumor Activity of Enzalutamide and Talazoparib (PF-06944076) for the Treatment of Metastatic Hormone-naïve Prostate Cancer


Condition: Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04332744

Sponsor: MedSIR

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Adult patients (>18 y.o.) who signed informed consent form (ICF) prior to participation in any study-related activities.
  2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
  4. High-volume metastatic disease documented on bone scan or computed tomography (CT)/magnetic resonance imaging (MRI) scan, defined as the presence of either visceral disease and/or at least four bone metastases on bone scan, with at least one of them beyond spine/pelvis.
  5. Life expectancy of ≥ 12 months.
  6. Histologically confirmed adenocarcinoma of the prostate without predominance of small-cell or neuroendocrine features according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines based on local testing on the most recent analyzed biopsy. Note: Central confirmation of adenocarcinoma is not required for study entry. However, tissue blocks, or slides, must be submitted to confirm the diagnoses by a Sponsor-designated central laboratory retrospectively and/or exploratory biomarker analyses.
  7. Willingness and ability to provide tumor paired biopsies during the study participation in order to perform exploratory studies. At the study entry, the most recent tumor biopsy since last progression from either metastatic or primary tissues will be provided. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee.
  8. Adequate hematologic and organ function within 28 days before the first study treatment on Cycle 1 Day 1, defined by the following:
  9. Hematological: White blood cell (WBC) count > 3.0 x 109/L; Absolute neutrophil count (ANC) > 1.5 x 109/L; Platelet count > 100.0 x109/L; Hemoglobin (Hb) > 9.0 g/dL. Note: Patients receiving growth factors or blood transfusions within 14 days before obtaining the hematology values at screening will be excluded.
  10. Hepatic: Total bilirubin ≤ 1.5 times the upper limit of normal (× ULN) (≤ 3 x ULN in the case of Gilbert's disease); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (in the case of liver metastases ≤ 5 × ULN); Alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN inthe case of liver and/or bone metastases).
  11. Renal: Serum creatinine < 1.5 × ULN or creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault glomerular filtration rate estimation.
  12. Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless on medication known to alter INR and/or aPTT.
  13. Nutritional status: Serum Albumin ≥ 2.8 g/dL.
  14. Bisphosphonates or denosumab dosage must have been stable for at least 4 weeks before Day 1 for patients receiving these therapies.
  15. Patients must agree to use a condom when is engaged in sexual activity with a pregnant woman during the treatment period and for at least 90 days after last dose of enzalutamide or at least 120 days after last dose of talazoparib (PF-06944076), whichever occurs later. Patients must also agree to use an additional highly effective form of contraception or two effective contraceptive methods, when is engaged in sexual intercourse with a woman of childbearing potential during the treatment period and for at least 90 days after last dose of enzalutamide or at least 120 days after last dose of talazoparib (PF-06944076), whichever occurs later.
  16. Must agree to refrain to donate sperm during the treatment period and for at least 90 days after last dose of enzalutamide or at least 120 days after last dose of talazoparib (PF-06944076), whichever occurs later.
  17. PSA ≥ 4 ng/mL at diagnosis or before starting ADT therapy.

Exclusion Criteria:

  1. Prior treatment with enzalutamide, apalutamide, darolutamide or abiraterone acetate.
  2. History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
  3. Known hypersensitivity to recombinant proteins, or any excipient contained in the drug formulation for talazoparib (PF-06944076) and enzalutamide.
  4. Prior systemic therapy for metastatic prostate cancer (mPCa). Note: Initiation of androgen deprivation therapy (ADT) within 4 weeks prior to study entry would be allowed (with or without first-generation antiandrogens), providing a tumor biopsy sample was taken prior to initiation of ADT is made available for biomarker studies and upon approval by the sponsor. If patient was started on first-generation antiandrogens, these would be discontinued on prior to randomization. Note: Patients relapsing after having received an ADT-based regimen in neoadjuvant or adjuvant setting will be suitable for the study if metastatic progression occured while on non-castrate testosterone levels or at least 12 months after discontinuation of ADT.
  5. Treatment with approved or investigational cancer therapy within 28 days (or 5 half-lives of the drug- whichever is longer) prior to initiation of study treatment.
  6. Known or suspected brain metastases or active leptomeningeal disease.
  7. Symptomatic or impending spinal cord compression or cauda equina syndrome.
  8. Subject has a history of seizure or any condition that may predispose to seizure (i.e. prior significant brain trauma, brain vascular malformations, ...), or subjects that have had unexplained loss of consciousness or transient ischemic attacks within 1 year prior to scheduled Day 1 of treatment.
  9. Therapeutic radiation therapy within 14 days (seven days for limited-field palliative radiotherapy) prior to study enrolment, or patients who have not recovered from radiotherapy-related toxicities to grade ≤ 1 according to National Cancer Insitute ́s Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v.)5.
  10. Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 14 days of start of study drugs, or patients who have not recovered from the side effects of any major surgery.
  11. History of another malignancy within three years of study enrollment with the exception of carcinoma in situ, non-melanoma skin carcinoma, or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the Sponsor's Medical Monitor is required, or any concurrent malignancy for which the patient is receiving therapy.
  12. Active uncontrolled infection at the time of enrollment.
  13. Congenital long QT syndrome or Electrocardiogram (ECG) at screening with QT interval corrected using Fridericia's formula (QTcF) > 500 milliseconds.
  14. Patients with clinically significant cardiovascular disease including but not limited to any of the following:
  15. Stroke, transient ischemic attack, unstable angina pectoris, or documented myocardial infarction within 12 months prior to study entry.
  16. Symptomatic pericarditis or clinically significant pericardial effusion or myocarditis.
  17. Documented congestive heart failure (New York Heart Association functional classification III- IV).
  18. Uncontrolled, persistent hypertension defined as systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg.
  19. Patients have any of the following cardiac conduction abnormalities:
  20. Ventricular arrhythmias except for benign premature ventricular contractions.
  21. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication.
  22. Conduction abnormality requiring a pacemaker.
  23. Other cardiac arrhythmia not controlled with medication.
  24. Patients have any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment contraindicate patient participation in the clinical study.
  25. Treatment with estrogens, cyprotoerone acetate or glucocorticoids (at a dose greater than the equivalent to 10 mg/day of prednisone) in the 4 weeks prior to scheduled Day 1 of treatment.
  26. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are employees of the trial sponsor, including their family members, directly involved in the conduct of the study.
  27. Concurrent participation in other clinical trial, except other translational studies or observational studies (defined as those with no therapeutic intervention).

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)


Condition: Metastatic Castrate Sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04497844

Sponsor: Janssen Research & Development, LLC

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Diagnosis of prostate adenocarcinoma
  • Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
  • Metastatic disease as documented by at least one bone lesion
  • Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and willing to continue through the treatment phase.
  • Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC): (a) maximum of 1 course of radiation or surgical intervention to manage symptoms of prostate cancer. Radiation with curative intent is not allowed. Radiation must be completed prior to randomization (b) <= 6 months of androgen deprivation therapy (ADT) prior to randomization; and (c) 30 days of abiraterone acetate + prednisone (AA-P) allowed if required

Exclusion Criteria:

  • Prior treatment with a poly (adenosine diphosphate-ribose) polymerase (inhibitor) (PARP) inhibitor- History of adrenal dysfunction
  • Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
  • History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03972657

Sponsor: Regeneron Pharmaceuticals

Phase: Phase 1/Phase 2

Eligibility:

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

Key Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
  • Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening ≥4 ng/mLthat has progressed within 6 months prior to screening as defined in the protocol
  • Has received ≥2 lines prior systemic therapy (in addition to androgen deprivation therapy [ADT]) with at least: 1. One line of a second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide) in the metastatic and/or castration-resistant setting 2. One additional systemic line of therapy approved for metastatic and/or castration-resistant disease
  • Adequate organ and bone marrow function

Key Exclusion Criteria:

  • Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities
  • Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy
  • Has received prior PSMA-targeting therapy
  • Dose Expansion Only: Has had prior anti-cancer immunotherapy
  • Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  • Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency NOTE: Other protocol defined Inclusion/

Exclusion Criteria:

  1. apply

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04302454

Sponsor: University Medical Center Groningen

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  1. Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
  2. Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 20
  3. BCR after surgery: PSA > 0.1ng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml or 3 consequent rises in PSA level (after exclusion of possible bounce effect).
  4. Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases.
  5. Nodal relapse (N1) in the pelvis on PSMA-PET/CT with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation.
  6. Nodal relapse (M1a) on PSMA-PET/CT above the aortic bifurcation with a maximum of 3 positive lymph nodes.
  7. Bone relapse on PSMA-PET/CT with a maximum of 3 lesions.
  8. Combination of a, b, c with a maximum of 4 metastases.
  9. Age > 18 years.
  10. Recent PSMA-PET/CT scan within 60 days prior to randomization.
  11. PSA < 10 ng/ml.
  12. In case of chronic use of finasteride the PSA value should be < 5 ng/ml.
  13. WHO performance state 0-
  14. Signed informed consent prior to registration/randomization.

Exclusion Criteria:

  1. Visceral metastases.
  2. PSA ≥ 10 ng/ml.
  3. PSA-doubling time ≤ 3 months.
  4. ADT or chemotherapy for recurrent PCa.
  5. Testosterone < 1.7 nmol/l
  6. Painful metastases needed pain medication (> level 1 pain medication) .
  7. Invasive active cancers other than superficial non-melanoma skin cancers.
  8. Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager AMG 160 in Subjects With Metastatic Castration-resistant Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03792841

Sponsor: Amgen

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting
  • Subject should have undergone bilateral orchiectomy or should be on continuous androgen-deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist or antagonist
  • Total serum testosterone
  • Evidence of progressive disease, defined as 1 or more PCWG3 criteria: PSA level >/=1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart, nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications, and/or appearance of 2 or more new lesions in bone scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0
  • 1
  • Life expectancy >/=6 months

Exclusion Criteria:

  • Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for >/= 30 days prior to randomization are eligible
  • Prior PSMA-targeted therapy (subjects on prior therapy may be eligible if discussed with Amgen medical monitor prior to enrollment)
  • Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
  • Active autoimmune disease or any other diseases requiring immunosuppressive therapy while on study
  • Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose
  • Myocardial infarction, unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 160 Part 2 only:
  • Subjects on a prior PD-1 or PD-L1 inhibitor who experienced a Grade 3 or higher immune-related adverse event prior to first day of dosing
  • History or evidence of interstitial lung disease or active, non-infectious pneumonitis Part 3 only: -Evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product Part 6 only: Subjects are excluded from this cohort if any of the following additional criteria apply:
  • Subjects taking strong OAT3 inhibitors (eg, probenecid) or adjust the dosing to 1 mg PO QD.
  • Subjects with latent or active tuberculosis at screening

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.


Condition: Hormone-Sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04493853

Sponsor: AstraZeneca

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 130 Years
  • Gender: Male

Inclusion Criteria:

  • Asymptomatic or mildly symptomatic, histologically-confirmed de novo metastatic hormone-sensitive prostate adenocarcinoma without small-cell tumours
  • Provide a FFPE tissue block (preferred) or slides. Tissue from bone metastases is not acceptable
  • A valid PTEN IHC result indicating PTEN deficiency (centralized testing)
  • Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion accurately assessed at baseline and suitable for repeated assessment with CT and/or MRI. PSMA PET identification only will not be eligible
  • Candidate for abiraterone and steroid therapy
  • Ongoing ADT with GnRH analogue, or LHRH agonists or antagonist, or bilateral orchiectomy (regardless of method) is from 0 days to a max. of 3 months prior to randomisation
  • Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
  • Able and willing to swallow and retain oral medication
  • 7-day Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory(BFI) questionnaires and the analgesic diary during screening completed
  • Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

  • Radiotherapy with a wide field of radiation within 4 weeks before the start of study treatment (capivasertib/placebo)
  • Major surgery (excluding placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of study treatment
  • Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)
  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
  • Any of the following cardiac criteria: i. Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive ECGs ii. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) iii. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval iv. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA or Class II to IV heart failure or cardiac ejection fraction measurement of < 50% v. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade ≥ 2 vi. Uncontrolled hypotension
  • systolic blood pressure (SBP) <90 mmHg and/or diastolic blood pressure (DBP) <50 mmHg vii. Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive) viii. Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 95 mmHg).
  • Clinically significant abnormalities of glucose metabolism as defined by any of the following: i. Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment ii. HbA1c ≥8.0% (63.9 mmol/mol)
  • Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: i. Absolute neutrophil count < 1.5x 109/L ii. Platelet count < 100x 109/L iii. Haemoglobin < 9 g/dL (< 5.59 mmol/L) iv. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases. Elevated alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigator's judgement v. Total bilirubin > 1.5x ULN (participants with confirmed Gilbert's syndrome may be included in the study with a higher value) vi. Creatinine > 1.5x ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5x ULN
  • As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or known active infection including hepatitis B, hepatitis C, and HIV
  • unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria: i. a "superscan" of bone scan, and ii. no soft tissue lesion that can be assessed by RECIST criteria
  • Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent
  • Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent
  • Previous allogeneic bone marrow transplant or solid organ transplant
  • Known additional malignancy that has had progression or has required active treatment in the last 3 years. Exceptions include basal cell carcinoma of the skin, and squamous cell carcinoma of the skin that has undergone potentially curative therapy
  • Treatment with any of the following: i. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment ii. Any investigational agents or study drugs from a previous clinical study within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment iii. Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long half-life (eg, biologics) iv. Potent inhibitors or inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week before the start of study treatment
  • Drugs known to prolong the QT interval within 5 half-lives of the first dose of study treatment
  • History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class
  • Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy.


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04186845

Sponsor: Blue Earth Diagnostics

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • 1. Patient is male and aged >18 years old. 2. History of localized adenocarcinoma of the prostate with prior curative intent treatment. 3. An elevated PSA, clinically suspicious for biochemically recurrent disease:
  • Following Radical Prostatectomy: PSA >0.2 ng/mL
  • Following Radiotherapy: nadir +2 ng/mL. 4. Potentially eligible for salvage therapy with curative intent.

Exclusion Criteria:

  1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
  2. Patients currently receiving Androgen Deprivation Therapy (ADT).

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase 2, Open-Label, Single-Arm Study of BGB-290 (BGB-290) for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Homologous Recombination Deficiency (HRD)


Condition: Metastatic Castration-Resistant Prostate Cancer (mCRPC), HRD

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03712930

Sponsor: BeiGene

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Men (> 18 years of age) with histologically or cytologically confirmed adenocarcinoma or poorly differentiated adenocarcinoma of the prostate without neuroendocrine differentiation with HRD deficiency by CTC-HRD assay and/or deleterious germline or somatic mutation in BRCA1 or BRCA2; mCRPC measurable disease and/or bone disease. • PSA progression with > 3 rising PSA levels with > 1 week between determinations and a screening PSA > 2 μg/L (2 ng/mL).
  • Must be surgically or medically castrated with serum testosterone levels of < 1.73 nmol/L (50 ng/dL), must have received > 1 prior androgen receptor-targeted therapy, and must have received > 1 taxane-based therapy.
  • mCRPC with 1 or 2 of the following:
  • Measurable disease per RECIST v1.1
  • Bone disease
  • CTC-HRD+ or BRCA1/2 mutation
  • PSA progression (PCWG3 criteria)
  • ≥1 androgen receptor-targeted therapy (eg, abiraterone acetate/prednisone or enzalutamide) for mCRPC with progressive disease
  • ≥1 taxane for metastatic prostate cancer
  • Prior sipuleucel-T and checkpoint inhibitors"

Exclusion Criteria:

  • Chemotherapy, hormonal therapy, biologic therapy, radionuclide therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or herbal remedies ≤ 5 half-lives if the half-life is known, ≤ 14 days if not known, before start of study treatment
  • Continued treatment with a bisphosphonate or denosumab is allowed, if administered at a stable dose > 28 days before start of study treatment
  • Radiotherapy ≤ 21 days (≤ 14 days, if single fraction of radiotherapy) before start of study treatment
  • Prior treatment for prostate cancer with any of the following:
  • PARP inhibitor
  • Platinum
  • Cyclophosphamide
  • Mitoxantrone"

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)


Condition: Metastatic Castrate Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03737370

Sponsor: Tufts Medical Center

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate
  2. Documented metastatic castration resistant disease with PSA progression, radiographic progression, or both, despite medical or surgical castration
  3. Two or more bone metastases detected on skeletal scintigraphy
  4. Eligible for docetaxel chemotherapy
  5. ECOG Performance Status 0-2
  6. Adequate organ function:
  7. Hemoglobin > 10 g/dL
  8. Absolute Neutrophil Count ≥ 1,500 K/mL
  9. Platelet count ≥ 150,000 x 10^9/L
  10. Total bilirubin ≤ 1.5x upper limit of normal range, excluding Gilbert syndrome
  11. Serum AST ≤ 1.5 x upper limit of normal range
  12. Serum ALT ≤ 1.5 x upper limit of normal range
  13. Estimated glomerular filtration rate (GFR) > 30mL/min
  14. Ongoing castration (androgen deprivation therapy or prior orchiectomy)
  15. Male subjects with female sexual partners of childbearing potential must agree to use at least one highly effective methods of birth control.
  16. Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures.
  17. Age ≥ 18 years

Exclusion Criteria:

  1. Prior radionuclide therapy for CRPC
  2. Prior docetaxel for CRPC. (Permitted if given for castration sensitive disease > 6 months prior).
  3. Antiandrogen therapy within 4 weeks of enrollment. However, patients with primary failure of secondary anti-androgen therapy OR symptomatic progression, objective progression and/or biochemical evidence of rising PSA less than 4 weeks after discontinuation of anti-androgen therapy will not have anti-androgen withdrawal responses and will not be excluded.
  4. Preexisting peripheral neuropathy grade 2 or higher.
  5. Other serious medical condition as judged by the investigator.
  6. Active second malignancy that requires therapy.
  7. Known brain or leptomeningeal metastases
  8. Concurrent enrollment in any other investigational anticancer therapy
  9. Treatment with any myelosuppressive agent within 30 days of enrollment
  10. Presence of bulky visceral metastases, defined as any of the following:
  11. ≥ 4 lung lesions (at least 1cm each in size in the longest diameter) or pulmonary lymphangitic metastasis
  12. Liver metastases with sum of lesion diameters totaling ≥ 5cm
  13. Evidence of neuroendocrine or small cell differentiation on prior biopsy
  14. History of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer


Condition: Metastatic Prostate Cancer, Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04446117

Sponsor: Exelixis

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Men with histologically or cytologically confirmed adenocarcinoma of the prostate
  • Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or mCSPC, M0 CRPC, or mCRPC
  • Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening
  • Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation)
  • Progressive disease at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible)
  • Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the day of consent
  • ECOG performance status of 0 or 1
  • Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator
  • Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization
  • Understanding and ability to comply with protocol requirements

Exclusion Criteria:

  • Any prior nonhormonal therapy initiated for the treatment of mCRPC
  • Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization
  • Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization (subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible)
  • Known brain metastases or cranial epidural disease unless adequately treated and clinically stable at least 4 weeks prior to randomization
  • Symptomatic or impending spinal cord compression or cauda equina syndrome
  • Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)
  • Administration of a live, attenuated vaccine within 30 days prior to randomization
  • Systematic treatment with, or any condition requiring, either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization
  • Uncontrolled, significant intercurrent or recent illness
  • Major surgery within 4 weeks prior to randomization
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per ECG within 21 days before randomization
  • Inability or unwillingness to swallow pills or receive IV administration
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies
  • Any other active malignancy at time of randomization or diagnosis of another malignancy within 2 years prior to randomization that requires active treatment (some exceptions apply such as locally curable cancers that have apparently been cured).

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03531099

Sponsor: Hospices Civils de Lyon

Phase: Phase 3

Eligibility:

  • Age: minimum 50 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  • Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
  • Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score > 14.
  • Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
  • Only one Target tumor on MRI on a maximum of 2 contigous sextants. Case allowed:
  • If more than one target tumor on MRI, only one of them must be confirmed by targeted prostate biopsies.
  • If no target tumor on MRI, only 2 contigous sextants must be positive on prostate biopsies
  • A maximum tumor length> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or MRI/Ultrasound Fusion-Guided Prostate Biopsy).
  • Gleason 6 score (risk group 1 of the D'Amico classification).
  • Tumor positioned so that a safety distance of at least 9 mm from external sphincter can be defined during HIFU-FOCAL treatment in prostate tissue around the target.
  • PSA ≤ 15ng / ml.
  • Patient affiliated with health insurance or beneficiary of an equivalent plan.

Exclusion Criteria:

  • Contraindications to treatment with HIFU-F:
  • Tumor not accessible.
  • Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
  • History of pelvic irradiation
  • Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
  • Fistula of the urinary tract or rectum.
  • Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
  • Anatomical abnormality of the rectum or rectal mucosa.
  • Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
  • History of intestinal inflammatory pathology.
  • Uro-genital infection in progress (the infection to be treated before HIFU treatment).
  • Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
  • Allergy to latex.
  • Thickness of the rectal wall> 10mm.
  • TURP indication. Bladder neck incision is allowed .
  • Patient with a medical contraindication to Sonovue® injection.
  • Patient with a medical contraindication on MRI.
  • Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
  • History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
  • History of sclerosis of the bladder neck or urethral stenosis.
  • Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy if randomized in HIFU-F arm).
  • Patients with unstable neurological pathology.
  • Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
  • Legal person protected by law.
  • Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Princess Margaret Cancer Centre 18F-DCFPyL PET Registry


Condition: Carcinoma of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03535831

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

  • Patients will be eligible for inclusion in this study if they meet all of the following criteria:
  • Age ≥ 18 years
  • Histologic diagnosis of carcinoma of prostate
  • Being staged or restaged for any of the following indications: A. Staging of patients with: i. High risk disease; defined as at least one of the following: a. Gleason ≥8, b. ≥T3 disease, c. PSA >20 ng/ml; ii. Unfavourable intermediate-risk disease defined as: a. more than one intermediate-risk factor (cT2b/ cT2c; GS=7; serum PSA of 10-20 ng/ml); or b. Gleason score of 4+3=7 or more; or c. greater than 50% positive biopsy cores. B. Staging or restaging of PCa with equivocal findings on conventional workup: i. Patients with PCa being staged or restaged with equivocal findings on conventional workup (CT, bone scan, MRI); to help guide management or select appropriate site for biopsy to establish disease status. C. Restaging of patients with: i. Biochemical failure (BCF) after primary therapy (radical prostatectomy or primary radiotherapy), or ii. BCF after salvage therapy/therapies when further treatment is being considered or iii. Pathologically involved nodes at time of radical prostatectomy or iv. Persistently detectable PSA (>0.1 ng/ml) >3 months after prostatectomy 5.1.4 Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Patients will be ineligible to participate in this study if they meet any of the following criteria:
  • Inability to lie still for PET/CT or PET/MR examination
  • For patients undergoing PET/MR only, any contraindication to MRI as per Joint Department of Medical Imaging policies (this exclusion criterion would not exclude patient from enrolling in the registry and undergoing PET/CT).
  • Patients with documented, clear-cut metastatic disease on conventional workup where PET findings would not potentially alter patient management. In case of uncertainty, the patient will be discussed at multidisciplinary tumor boards and a majority decision will be made

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

68GA-PSMA FUSION PET/MRI FOR IMAGE-GUIDED PROSTATE BIOPSIES


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03689582

Sponsor: University of Michigan Rogel Cancer Center

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
  • Treating physician has already indicated a need for a prostate biopsy procedure.
  • Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

Exclusion Criteria:

  • Prostate biopsy within 12 weeks before enrollment
  • Acute prostatitis within the last 6 months
  • Current non-urologic bacterial infection requiring active treatment with antibiotics
  • Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
  • Body weight greater than 350 lbs (158 Kg)
  • Inability or unwillingness to receive a prostate biopsy procedure
  • Unable to lie flat, still, or tolerate a PET/CT scan
  • Unable to provide own consent
  • Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase Ib, Open-Label, Multicenter Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer.


Condition: Castration-Resistant Prostatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04404140

Sponsor: Hoffmann-La Roche

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Ability to comply with the study protocol.
  • Adenocarcinoma of the prostate without small-cell or neuroendocrine features.
  • Metastatic disease that cannot be treated with curative intent.
  • Surgical or medical castration with testosterone serum level < 50 ng/dL (1.7 nM).
  • For participants treated with luteinizing hormone-releasing hormone analogs, initiation therapy >= 4 weeks prior to the first dose of study treatment and continued therapy throughout study treatment.
  • Progression of Prostate Cancer.
  • Receipt of at least one prior line of second generation AR-targeted therapy.
  • For participants in Part A of study: measurable visceral disease or measurable extrapelvic adenopathy per RECIST v1.1.
  • For participants in Part B of study: either measurable visceral disease or measurable extrapelvic adenopathy by RECIST v1.1 or bone lesions by bone scan, or both.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Life expectancy of >= 3 months.
  • Ability to swallow oral study drug.
  • Adequate organ and bone marrow function.
  • Resolved or stabilized toxicities resulting from previous therapy to Grade 1 (except for alopecia and neuropathy).
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. Exclusion Criteria:
  • Prior treatment with an AKT, PI3K, or mTOR inhibitor.
  • Prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer.
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
  • Prior treatment with docetaxel or another chemotherapy agent for mCRPC.
  • Treatment with investigational therapy within 14 days prior to initiation of study drug.
  • History or known presence of central nervous system metastases including leptomeningeal carcinomatosis.
  • Uncontrolled tumor-related pain.
  • Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment.
  • Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco- regional therapy if appropriate prior to enrollment.
  • Non-study-related minor surgical procedures =< 5 days or major (invasive) surgical procedure =< 28 days prior to the first dose of study treatment.
  • Active Hepatitis B and C infection (HBV/HCV).
  • Known HIV infection.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites.
  • Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment.
  • Malabsorption syndrome or other condition that would interfere with enteral absorption.
  • Serious infection requiring antibiotics within 14 days prior to the first dose of study treatment.
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
  • History of another malignancy within 5 years prior to enrollment.
  • History of clinically significant cardiovascular dysfunction.
  • Presence of any other condition, metabolic dysfunction, physical examination finding, or laboratory finding that may increase the risk associated with study participation or may interfere with the interpretation of study results and in the opinion of the investigator, would make the participant inappropriate for study entry. Ipatasertib-Specific Exclusion Criteria:
  • Type 1 or Type 2 diabetes mellitus requiring insulin at study entry.
  • History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).
  • Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
  • Treatment with strong CYP3A inhibitor or strong CYP3A inducer within 2 weeks or 5 drug-elimination half-lives of this treatment (whichever is longer) prior to initiation of study drug. Atezolizumab-Specific Exclusion Criteria:
  • Active or history of autoimmune disease or immune deficiency.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the last dose of atezolizumab.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies.
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug (whichever is longer) prior to initiation of study treatment.
  • Need for chronic corticosteroid therapy of >10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease.
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study. Docetaxel-Specific

Exclusion Criteria:

  • Prior treatment with an AKT, PI3K, or mTOR inhibitor.
  • Prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer.
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
  • Prior treatment with docetaxel or another chemotherapy agent for mCRPC.
  • Treatment with investigational therapy within 14 days prior to initiation of study drug.
  • History or known presence of central nervous system metastases including leptomeningeal carcinomatosis.
  • Uncontrolled tumor-related pain.
  • Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment.
  • Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco- regional therapy if appropriate prior to enrollment.
  • Non-study-related minor surgical procedures =< 5 days or major (invasive) surgical procedure =< 28 days prior to the first dose of study treatment.
  • Active Hepatitis B and C infection (HBV/HCV).
  • Known HIV infection.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites.
  • Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment.
  • Malabsorption syndrome or other condition that would interfere with enteral absorption.
  • Serious infection requiring antibiotics within 14 days prior to the first dose of study treatment.
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
  • History of another malignancy within 5 years prior to enrollment.
  • History of clinically significant cardiovascular dysfunction.
  • Presence of any other condition, metabolic dysfunction, physical examination finding, or laboratory finding that may increase the risk associated with study participation or may interfere with the interpretation of study results and in the opinion of the investigator, would make the participant inappropriate for study entry. Ipatasertib-Specific Exclusion Criteria:
  • Type 1 or Type 2 diabetes mellitus requiring insulin at study entry.
  • History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).
  • Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
  • Treatment with strong CYP3A inhibitor or strong CYP3A inducer within 2 weeks or 5 drug-elimination half-lives of this treatment (whichever is longer) prior to initiation of study drug. Atezolizumab-Specific Exclusion Criteria:
  • Active or history of autoimmune disease or immune deficiency.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the last dose of atezolizumab.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies.
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug (whichever is longer) prior to initiation of study treatment.
  • Need for chronic corticosteroid therapy of >10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease.
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study. Docetaxel-Specific Exclusion Criteria:
  • Known hypersensitivity or contraindication to any component of docetaxel, including its excipient polysorbate 80.
  • Grade >= 2 peripheral neuropathy.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Phase II Randomized Study Of Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide For Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02903368

Sponsor: Dana-Farber Cancer Institute

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Male ≥ 18 years of age. 2. Histologically confirmed adenocarcinoma of the prostate without histological variants comprising >50% of the sample as determined by academic center central review (including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma). 3. Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within seven months from screening. Less than 3 core biopsies are allowed if the patient has >1 cm or T3 disease on MRI. 4. Patients must have the following features:
  • Gleason ≥ 4+3=7 OR
  • Gleason 3+4=7 AND at least one of the following: PSA >20 ng/dL or T3 disease (as determined by MRI). 5. No evidence of metastatic disease as determined by radionuclide bone scans and CT/MRI. Lymph nodes must be less than 20 mm in the short (transverse) axis. 6. Participants must be candidates for RP and considered surgically resectable by urologic evaluation. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 8. Participants must have normal organ and marrow function as defined below:
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start
  • Serum potassium ≥ 3.5 mmol/L
  • Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible)
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Serum albumin ≥ 3.0 g/dL
  • Serum creatinine < 2.0 x ULN
  • PTT≤60 9. Participant must agree to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or must agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Participant must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug. 10. Medications known to lower the seizure threshold (see list under APPENDIX D: Representative Medications that May Predispose to Seizure) must be discontinued or substituted at least 1 week prior to study treatment.

Exclusion Criteria:

  • 1. Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, Apalutamide and others), CYP17 inhibitors (including abiraterone acetate, TAK-700, galeterone, ketoconazole, and others), estrogens, Luteinizing Hormone Releasing Hormone (LHRH) agonist/antagonists. Prior therapy with 5α-reductase inhibitors is allowed. LHRH therapy allowed if begun within 4 weeks of day 1. 2. Prior chemotherapy, radiation therapy, or immunotherapy for prostate cancer. 3. Prior systemic treatment with an azole drug within two weeks of start of treatment. 4. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone < 200 ng/dL. 5. Clinically significant cardiovascular disease within 6 months of study treatment including:
  • Severe or unstable angina;
  • Myocardial infarction;
  • Symptomatic congestive heart failure;
  • New York Heart Association (NYHA) class II-IV heart disease;
  • Arterial or venous thromboembolic events (such as pulmonary embolism cerebrovascular accident including transient ischemic attacks);
  • History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  • Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening EKG > 470 msec;
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
  • Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy. 6. History of seizure or any condition or concurrent medication that may predispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect). 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Apalutamide, abiraterone acetate, or other study drugs. 8. Severe hepatic impairment (Child-Pugh Class C). 9. Active infection (such as human immunodeficiency virus (HIV) or viral hepatitis) or other medical condition that would make prednisone / prednisolone corticosteroid use contraindicated. 10. History of pituitary or adrenal dysfunction. 11. Gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug. 12. 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, or inhaled corticosteroids are permitted. 13. Concomitant use of medications that may alter pharmacokinetics of abiraterone acetate or Apalutamide. 14. Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1) individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, or 2) individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-muscle invasive bladder cancer, basal cell or squamous cell carcinoma of the skin. 15. Major surgery or radiation therapy within 30 days of screening visit. Participants who have had a major surgery within 30 days of screening visit may be eligible provided the treating investigator deems that the participant is at low risk for complications. 16. Any condition that in the opinion of the investigator would preclude participation in this study.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03800784

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Phase 2/Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histological confirmation of prostate cancer
  • Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration.
  • Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both)
  • Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT
  • Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months.
  • Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)
  • PSADT ≤ 9 months
  • Cohort B: mCRPC
  • Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted).
  • PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT
  • Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility.
  • No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced.
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

  • Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

177Lu-PSMA-I&T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04188587

Sponsor: Nanjing First Hospital, Nanjing Medical University

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 90 Years
  • Gender: Male

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, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
  2. Hemoglobin<80g/L;Hemameba<2.5×109/L;Thrombocyte<70g/L
  3. Glomerular filtration rate<50ml/min
  4. Serum creatinine>130umol/L;Total bilirubin>2mg/L;Albumin<30g/L.
  5. International normalized ratio(INR)>1,5
  6. Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Subjects With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)


Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04108208

Sponsor: Janssen Research & Development, LLC

Phase: Phase 4

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equals to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous androgen deprivation therapy (ADT)
  • Castration-resistant prostate cancer (PC) demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA greater than (>) 2 nanogram per milliliter (ng/mL)
  • Surgically or medically castrated, with testosterone levels of less than (<) 50 nanogram per deciliter (ng/dL). If the participant is medically castrated, continuous dosing with gonadotropin releasing hormone analog (GnRHa) must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone
  • Participants who received a first-generation anti-androgen (example: bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after washout
  • At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization

Exclusion Criteria:

  • Presence of distant metastases, including central nervous system (CNS) and vertebral or meningeal involvement, or history of distant metastases. Exception: Pelvic lymph nodes <2 centimeter 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 (example, tumor obstruction of bladder trigone)
  • Prior treatment with cytochrome P450 17 alpha-hydroxylase/17,20-lyase (CYP17) inhibitors (example: abiraterone acetate, orteronel, galerterone, ketoconazole, aminoglutethimide) for PC
  • Prior chemotherapy for PC, except if administered in the adjuvant/neoadjuvant setting
  • History of seizure or condition that may pre-dispose to seizure (example: prior stroke within 1 year prior to randomization, brain arteriovenous malformation, schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase II Clinical Study of SHR3680 Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer Previously Treated With Abiraterone and Docetaxel


Condition: Prostate Cancer, Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04102124

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Histologically or cytologically confirmed prostate cancer; does not suggest neuroendocrine or small cell characteristics
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
  3. Radiographic evidence of metastasis;
  4. Sustained therapy of luteinizing hormone-releasing hormone analogue(LHRHA)or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;
  5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
  6. Adequate hepatic, renal, heart, and hematological functions;
  7. Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
  8. Patient has been treated with Abiraterone and treatment failed(Treatment failure is defined as the progression of disease during treatment)
  9. Patient has been treated with Docetaxel and treatment failed or can not tolerate docetaxel chemotherapy or patients who are not suitable for docetaxel treatment at the time of screening.

Exclusion Criteria:

  1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
  2. Planned to initiate any other anti-tumor therapies during the study;
  3. Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
  4. Clinically significant cardiovascular diseases;
  5. History of seizure or certain conditions that may predispose to seizure;
  6. Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}