Prostate Cancer

{{header-clinical-trials-navigation}}

Phase I/II Dose-escalation Study of Fractionated and Multiple Dose 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04506567

Sponsor: Weill Medical College of Cornell University

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically or cytologically confirmed adenocarcinoma of prostate 2. 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 3. 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 4. 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) 5. Have previously received taxane chemotherapy (in any disease state), been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy. 6. Age > 18 years 7. Patients must have normal organ and marrow function as defined below:
  • Absolute neutrophil count >2,000 cells/mm3
  • Hemoglobin ≥9 g/dL
  • Platelet count >150,000 x 109/uL
  • Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 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) 8. ECOG performance status of 0-2 9. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. Implantation of investigational medical device ≤4 weeks of Treatment Visit 1 (Day 1) or current enrollment in oncologic investigational drug or device study
  2. Use of investigational drugs ≤4 weeks or <5 half-lives of Cycle 1, Day 1 or current enrollment in investigational oncology drug or device study
  3. Prior systemic beta-emitting bone-seeking radioisotopes
  4. Known active brain metastases or leptomeningeal disease
  5. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
  6. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
  7. Radiation therapy for treatment of PC ≤4 weeks of Day 1 Cycle 1
  8. 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
  9. Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration
  10. Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse
  11. Known history of myelodysplastic syndrome

View trial on ClinicalTrials.gov


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

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression


Condition: Metastatic Castration-resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC)

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:

  1. mCRPC cohorts:
  2. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
  3. Prostate specific antigen (PSA) value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.
  4. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy [ADT]) including at least:
  5. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
  6. post-177Lu-PSMA-617 radiotherapy expansion cohort only. Must have received at least 2 doses of 177Lu-PSMA-6
  7. ccRCC cohorts:
  8. Men and women with histologically or cytologically confirmed RCC with a clear-cell component.
  9. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
  10. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-programmed death-1 (receptor) [PD-1]/programmed death-ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor

Key Exclusion Criteria:

  1. 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, as described in the protocol
  2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
  3. Has received prior PSMA-targeting therapy with the exception of approved radiopharmaceutical therapy (eg. 177Lu-PSMA-617) in mCRPC patients
  4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
  5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as describe in the protocol
  6. 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
  7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  8. 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
  9. 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 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 2 Study of a Checkpoint Inhibitor in Men With Progressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation


Condition: Metastatic Castration Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04104893

Sponsor: VA Office of Research and Development

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Subject must be 18 years of age or older at the time the Informed Consent is signed.
  • The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial.
  • Pathologic diagnosis of prostate cancer of adenocarcinoma or small cell histology.
  • Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). CT-portion of FDG-PET/CT or scan may be used for eligibility. NaF PET-CT is an alternative to 99mTc bone scan. If lymph node metastasis is the only evidence of metastatic disease, it must be 1.5 cm in short axis and above the level of the iliac bifurcation. Imaging studies for the purpose of determining eligibility must be completed within 60 days of Day 1.
  • Progressive castration resistant prostate cancer as defined by serum testosterone < 50 ng/mL and one of the following:
  • PSA progression confirmed per Prostate Cancer Clinical Trials Working Group (PCWG3),
  • Radiographic progression of soft tissues according to Response Evaluation Criteria in Solid Tumors, version 1.1 (iRECIST 1.1) modified based on PCWG3, or radiographic progression of bone according to PCWG3.
  • Prior use of a novel AR signaling inhibitor for 4 weeks, including abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and/or darolutamide. NOTE: These AR signaling inhibitors may have been used for mCSPC, M0CRPC, and/or mCRPC.
  • Ongoing surgical or medical castration, with testosterone levels of <50 ng/dL. If the subject is being treated with GnRH analogs (subject who has not undergone bilateral orchiectomy), this therapy must have been initiated at least 30 weeks prior to initiation of pembrolizumab and must be continued throughout the study.
  • ECOG PS grade of 0-1.
  • Metastatic lesion that is amenable to biopsy and performed within 180 days of Day 1.
  • dMMR or CDK12-/- as determined by somatic tumor DNA NGS.
  • Either monoallelic or biallelic inactivation of CDK12 on NGS is considered sufficient for eligibility purposes.
  • MMR genes include: MLH1, MSH2, MLH3, PMS1, MSH6, and PMS2.
  • dMMR is established by MSI-H on NGS. However, for "weak" MMR genes, inclusive of PMS2 and MSH6, monoallelic inactivation will be allowed for eligibility purposes if and only if there is at least MSI-low or hypermutation that is concomitantly present.
  • If there is biallelic inactivation of "strong" MMR genes (MLH1 and MSH2), then patients must manifest MSI-H. However, if the tumor DNA utilized for MSI analysis was obtained > 6 months prior to NGS, then the NGS should be repeated to determine if MSI-H has developed. Monoallelic inactivation of "strong" MMR genes will be allowed if MSI-H is present; in this scenario, it is presumed that biallelic inactivation is present but the second inactivating event was not detected due to technical issues such as low sensitivity for copy loss.
  • Adequate organ function:
  • Hemoglobin (hgb) > 9.0 g/dL,
  • Absolute neutrophil count (ANC) > 1500/ uL,
  • Platelets > 100,000/ uL,
  • Total bilirubin 1.5 x ULN OR direct bilirubin ULN for participants with total bilirubin levels >1.5 x ULN
  • ALT and AST 2.5 x ULN ( 5 x ULN for participants with liver metastases) (Child-Pugh class A and B allowed; Child-Pugh class C is excluded).
  • Creatinine < (2.0 mg/dL) during screening evaluation (>2.0 is allowed if EGFR >30 mL/min/1.73 m2).
  • Subject must agree to use contraception during the treatment period plus an additional 120 days after the last dose of study treatment and must refrain from donating sperm during this period.

Exclusion Criteria:

  • Brain metastases.
  • Prior treatment with an anti-PD1, anti-PDL1, 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).
  • Anti-neoplastic therapies for prostate cancer must be completed > 2 weeks prior to Day 1 (initiation of pembrolizumab); chemotherapy must be completed > 4 weeks prior to Day 1.
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to [randomization /allocation]. Note: Participants must have recovered from all AEs due to previous therapies to Grade 1 or baseline. Participants with Grade 2 neuropathy may be eligible.
  • Herbal and non-herbal products that may decrease PSA levels other than medical castration and megestrol (up to 40 mg/day is allowed) for hot flashes.
  • Has received prior radiotherapy within 2 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.
  • 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 treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention within 4 weeks prior to starting therapy.
  • History of non-prostate active malignancy requiring treatment in the 24 months prior to Day 1 except for non-muscle invasive urothelial cancer and non-melanoma skin cancer.
  • Active infection or conditions requiring treatment with antibiotics.
  • Immunosuppressive doses of systemic medications, such as corticosteroids (doses > 10 mg/day prednisone or equivalent), within 2 weeks of Day 1.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • 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.
  • Active autoimmune disease or a documented history of autoimmune disease that requires immunosuppressive medications within the last two years (e.g., chronic steroids, methotrexate, tacrolimus, etc.).
  • Active or chronic hepatitis B or hepatitis C disease as determined by hepatitis B surface antigen (HBsAg), hepatitis B core antibody, or hepatitis C antibody (anti-HCV) positivity at screening. If positive, further testing of quantitative levels to rule out active infection is required.
  • History of positive test for human immunodeficiency virus (HIV). NOTE: Hepatitis B and C and HIV testing is NOT required during screening.
  • Vaccinated with a live vaccine within 30 days of enrollment.
  • Has severe hypersensitivity ( Grade 3) to pembrolizumab and/or any of its excipients.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Subject is planning 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.

View trial on ClinicalTrials.gov


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

Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04086290

Sponsor: Peter Busch Østergren

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Age 18 years or older and willing and able to provide informed consent;
  2. Stage cT1 ≤ cT3b, Clinical resectable
  3. Gleason score ≥ 6
  4. M1
  5. ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
  6. Absence of PSMA uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the European Association of Urology (EAU) guidelines.
  7. No visceral metastasis
  8. Metastases suitable for stereotactic body radiotherapy
  9. Non symptomatic bone lesions
  10. Eligible for surgery

Exclusion Criteria:

  1. Prior curative intended treatment for prostate cancer
  2. Prior androgen deprivation therapy (ADT)
  3. History of another invasive cancer within 3 years of screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote for exceptions.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status > 1
  5. Evaluated not able to fulfil the study protocol.
  6. Contraindications against MRI

View trial on ClinicalTrials.gov


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

An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04181203

Sponsor: UNICANCER

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  1. Patients must have signed a written informed consent form prior to any trial specific procedures
  2. Age ≥18 years old and ≤80 years old
  3. Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with radical prostatectomy
  4. Pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx])
  5. Tumor stage pT2, pT3 or pT4* (*only in case of bladder neck involvement)
  6. Patients should have no clinical and radiological signs (18FCH-PET CT-scan or 68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse detected on PET CT-scan can be randomized
  7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  8. PSA ≥0.2 ng/mL at the time of randomization with an elevation of PSA over three consecutive assays. PSA increases over a 1-month interval minimum
  9. At least 3 months between radical prostatectomy and randomization.
  10. High-risk features as defined by at least one of these characteristics: PSA at relapse >0.5 ng/mL or Gleason score >7 or tumor stage pT3b or resection margins R0 or PSA doubling time ≤6 months
  11. Adequate renal function: serum creatinine <1.5 x upper limit of normal (ULN) or a calculated corrected creatinine clearance ≥60 mL/min according to the Cockcroft-Gault formula, creatinemia <2 ULN
  12. Adequate hepatic function: total bilirubin ≤1.5 x ULN (unless documented Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN
  13. Patients with QTc prolongation <500 ms, inclusion should considered after close benefit/risk assessment and cardiologist advice
  14. Patients with female partners of reproductive potential should agree to use effective contraceptive method during treatment period and for 3 months after the last dose of apalutamide or for 6 months after the last fraction of radiotherapy
  15. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
  16. Patients must be affiliated to the Social Security System

Exclusion Criteria:

  1. Histologically proven lymph nodes involvement at initial lymphadenectomy: pN1, pN2, pN3
  2. Previous treatment with hormone therapy for prostate cancer
  3. Histology other than adenocarcinoma
  4. Surgical or chemical castration
  5. Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years
  6. Previous pelvic radiotherapy
  7. History of Inflammatory bowel disease or any malabsorption syndrome or conditions that would interfere with enteral absorption
  8. Uncontrolled hypertension (defined as systolic blood pressure (BP) ≥140 mmHg or diastolic BP ≥90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
  9. Clinically significant history of liver disease consistent with Child-Pugh class B or C
  10. History of seizure or condition that may pre-dispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  11. Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
  12. Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g pulmonary embolism, cerebrovascular accident including transient ischemic attacks) or clinically significant ventricular arrhythmias within 6 months prior to randomization
  13. Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (e.g, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >500 ms at baseline
  14. Medications known to prolong QTc
  15. Known hypersensitivity to apalutamide or to any of its components
  16. Galactosemia, Glucose-galactose malabsorption or lactase deficiency
  17. Inability or willingness to swallow oral medication
  18. Individual deprived of liberty or placed under the authority of a tutor
  19. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within the 30 days before inclusion

View trial on ClinicalTrials.gov


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

Postoperative Hypofractionated Radiation Therapy and Hormonal Therapy in Patients With Prostate Cancer: A Phase II Trial


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04249154

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement, Gleason score >7) adenocarcinoma of the prostate after a radical prostatectomy as primary treatment (adjuvant group), with pathologically negative lymph nodes dissection or clinically negative lymph nodes by imaging [pelvic and abdominal computed tomography (CT) scan, or magnetic resonance imaging (MRI)]. Lymphadenectomy is not mandatory. Any type of prostatectomy will be permitted. For this group of patients, the PSA level at time of entry must be below 0.4 ng/ml
  • Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or clinically negative lymph nodes by imaging (pelvic and abdominal CT scan, or MRI or) and evidence of biochemical failure (defined as two consecutives rises of the PSA, at any PSA level). PSA upper limit post-prostatectomy must be below 2.0 ng/ml (salvage group). Any type of prostatectomy will be permitted
  • Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed
  • History and physical examination (including digital rectal exam) within 90 days prior of registration
  • Adequate marrow reserve defined as: Hemoglobin ≥ 10 g/dl (patients may be transfused in order to achieve this level); Platelets ≥ 100 000 cells/mm3 and a white blood cell count of ≥ 4000 cells/ml3
  • AST or ALT <2 x the upper limit of normal
  • PSA and testosterone levels within one month of registration Age ≥ 18
  • Zubrod Performance Status 0-1
  • Patients must sign a study-specific consent form

Exclusion Criteria:

  • Previous exposure to androgen deprivation
  • Chemotherapy before or after prostatectomy
  • Prior pelvic radiotherapy
  • Previous malignancies (except non-melanomatous skin cancer) unless disease-free >5 years
  • Severe, active medical condition that makes the use of any of the therapies of the study not recommended

View trial on ClinicalTrials.gov


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

Developing and Testing an Interactive Decision Aid for Newly Diagnosed Prostate Cancer Patients


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04260737

Sponsor: Reykjavik University

Eligibility:

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

Inclusion Criteria:

  • Newly diagnosed with localized prostate cancer.

Exclusion Criteria:

  • Reads and understands Icelandic
  • Can give informed consent

View trial on ClinicalTrials.gov


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

Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04269512

Sponsor: Martini-Klinik am UKE GmbH

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  • localized intermediate risk prostate cancer (intermediate risk (PSA> 10 ng / ml
  • 20 ng / ml or Gleason score 7 or cT category 2b)
  • scheduled for open radical prostatectomie or DaVinci prostatectomie

Exclusion Criteria:

  • American Society of Anesthesiology Classification> 3
  • Existing contraindications for performing a lymph node dissection
  • Neoadjuvant hormone therapy

View trial on ClinicalTrials.gov


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

Prebiopsy Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer - A Multi-centre Trial on Clinical Utility of IMPROD bpMRI in a Shared Decision Making Setting


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04287088

Sponsor: Turku University Hospital

Eligibility:

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

Inclusion Criteria:

  • Age: 18 years or older
  • Language spoken: Finnish
  • Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 ng/ml and/or abnormal digital rectal examination according to the referral physician
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

  • previous diagnosis of prostate cancer
  • any contraindications for MRI
  • any other conditions that might compromise patient's safety, based on the clinical judgment of the responsible urologist
  • bilateral hip prosthesis

View trial on ClinicalTrials.gov


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

Hypofractionated Radiosurgery for Localised Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03795337

Sponsor: University Hospital Schleswig-Holstein

Eligibility:

  • Age: minimum 60 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0
  • Gleason-grade ≤7
  • Guideline-based staging
  • Age ≥ 60 years
  • PSA < 15 ng / ml
  • Volume of the prostate < 80 cm³
  • IPSS-Score ≤ 12
  • Written informed consent

Exclusion Criteria:

  • Age ≤ 60 years
  • History of prior pelvic radiotherapy
  • Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
  • Immunosuppressive therapy
  • Relevant comorbidity thought to adversely affect treatment compliance,
  • Legal incapacity or lack of informed consent

View trial on ClinicalTrials.gov


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

Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04263025

Sponsor: Hackensack Meridian Health

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 30 Years maximum 70 Years
  • Gender: Male

Inclusion Criteria:

  1. Male aged between 30 and 70 years old
  2. Primary diagnosis of organ confined prostate cancer
  3. Scheduled to undergo bilateral, nerve-sparing RARP
  4. Patient has ICIQ-SF score <6
  5. Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)
  6. Patient is willing to return for all visits as defined in the protocol
  7. Patient is willing to follow the instruction of the Investigator
  8. Patient has provided written informed consent

Exclusion Criteria:

  1. Previous history of pelvic radiation
  2. Previous history of simple prostatectomy or transurethral prostate surgery
  3. Previous history of systemic therapy for prostate cancer
  4. Patient has neurogenic bladder
  5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
  6. History of open pelvic surgery within 5 years except for hernia repair
  7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
  8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
  9. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
  10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

View trial on ClinicalTrials.gov


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

ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03903835

Sponsor: Karolinska Institutet

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Man with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing newly diagnosed (i.e. de novo) hormone sensitive prostate cancer (mHSPC) or first-line castration resistant prostate cancer (mCRPC)
  • Distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI
  • Adequate health as assessed by the investigator to receive all available treatments in the trial
  • ECOG/WHO (Eastern Cooperative Oncology Group/ World Health Organization) performance score 0-2
  • Adequate organ and bone marrow function
  • Albumin greater than or equal to 28 g/L
  • Able to understand the patient information and sign written informed consent

Exclusion Criteria:

  • Other malignancies within 5 years except non-melanoma skin cancer
  • Within 6 months of randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA (transient ischemic attack), or congestive heart failure NYHA (New York Heart Association) class III or IV
  • Uncontrolled hypertension
  • Uncontrolled hypotension
  • Received systemic therapy (with the exception of standard ADT) prior to study inclusion, for the CRPC indication
  • Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
  • Unable to comply with study procedures
  • Current participation in another clinical trial that will be in conflict with the present study, administration of an investigational therapeutic or invasive surgical procedure within 28 days prior to study enrolment
  • Patients who are unlikely to comply with the protocol
  • Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subjects participation in this study.
  • Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease.

View trial on ClinicalTrials.gov


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

A Phase I Trial of Enzalutamide Plus the Glucocorticoid Receptor Antagonist CORT-125134 (Relacorilant) for Patients With Metastatic Castration Resistant Prostate Cancer (CRPC)


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03674814

Sponsor: University of Chicago

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically or cytologically confirmed prostate cancer with documented metastatic disease 2. Evidence of castrate testosterone level <50ng/dl (or surgical castration) 3. Evidence of disease progression:
  • 2 or more new lesions on bone scan or
  • Progressive disease on CT/MRI according to Response Evaluation Criteria in Solid Tumors 1.1 criteria or
  • Rising Prostate Specific Antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart. 4. Prior treatment with at least one line of potent androgen receptor signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide) in either castration-sensitive or castration-resistant setting. 5. Any prior therapy for castrate disease is acceptable except prior GR antagonist treatment (e.g. mifepristone or relacorilant). 6. Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug. 7. Denosumab or zoledronic acid are allowed. 8. ECOG performance status ≤ 2. 9. Patients must have normal hepatic function as defined below:
  • Total bilirubin
  • AST(SGOT)/ALT(SGPT)
  • Albumin >/=3.0 g/dL 10. Patients must have normal bone marrow function as defined below:
  • Platelet count (plt) >/= 80,000 /microliter
  • Hemoglobin (Hgb) >/= 9 g/dL
  • Absolute neutrophil count (ANC) >/= 1500 11. Patients must have normal renal function as defined below:
  • GFR >/= 30 mL/min 12. Ability to understand and the willingness to sign a written informed consent document. 13. Patients with active Diabetes Mellitus on glucose lowering medications are eligible provided they agree to and are able to self-monitor daily blood glucose levels due to potential risk of lowering glucose levels on relacorilant. 14. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
  • Condom (barrier method of contraception); AND
  • One of the following is required: 1. Established use of oral, or injected or implanted hormonal method of contraception by the female partner; 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; 3. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner; 4. Tubal ligation in the female partner; 5. Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months.

Exclusion Criteria:

  1. Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid within 2 weeks prior to first dose of study drug. a.Patients who have been on systemic corticosteroids with prednisone equivalent of 10mg or greater for greater than 3 months immediately prior to participation in this study must have documented ability to tolerate cessation of corticosteroids prior to enrollment.
  2. Inability to swallow capsules or known gastrointestinal malabsorption.
  3. Evidence of visceral disease on imaging in a patient who is an appropriate candidate for cytotoxic chemotherapy (docetaxel or cabazitaxel).
  4. History of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 malignancies who are without evidence of disease, or other cancers curatively treated with no evidence of disease for > 5 years from enrollment.
  5. Blood pressure that is not controlled despite > 2 oral agents (SBP >160 and DBP >90 documented during the screening period with no subsequent blood pressure readings >160/100).
  6. History of seizure disorder or active use of anticonvulsants. Medications used to treat neuropathic pain such as gabapentin or pregabalin are allowed.
  7. Documented history of or current brain metastases due to seizure risk
  8. Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled.
  9. Active psychiatric illness/social situations that would limit compliance with protocol requirements.
  10. NYHA class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure).
  11. Concurrent therapy with strong inhibitors or inducers of CYP3A4 or CYP2C8 (See Section 9.12below for list of strong inhibitor or inducers) due to concerning possible drug-drug interactions
  12. Presence of concurrent medical conditions requiring systemic glucocorticoids for immunosuppression (e.g. Autoimmune diseases, organ transplantation) that is active and has required glucocorticoids in the last 6 months.

View trial on ClinicalTrials.gov


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

An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination, in Patients With Advanced Solid/Metastatic Tumours.


Condition: Metastatic Castration-Resistant Prostate Cancer, Metastatic Breast Cancer, Non-small Cell Lung Cancer, Advanced Solid Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03568656

Sponsor: CellCentric Ltd.

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Provision of consent
  • ECOG performance status 0-1
  • Assessable disease (by CT, MRI, bone scan or X-ray)
  • Adequate organ function
  • Highly effective contraception measures for duration of study Additional inclusion criteria for mCRPC patients only:
  • Previously received abiraterone and/or enzalutamide (or equivalent anti-androgen), and docetaxel (unless ineligible or refused)
  • Progressive disease documented by one or more of the following:
  • Biochemical progression defined as at least 2 stepwise increases in a series of any 3 PSA values
  • Progression as defined by RECIST v1.1 guideline for assessment of malignant soft tissue disease.
  • Progression defined as two or more new metastatic bone lesions confirmed on bone scan from a previous assessment
  • PSA at screening ≥2 μg/L
  • Serum testosterone concentration ≤50 ng/dL
  • Serum albumin >2.5 g/dL Additional inclusion criteria for patients in CCS1477 plus abiraterone combination arm:
  • Patients must have previously progressed on abiraterone treatment
  • Patients whose last dose of abiraterone is greater than 6 months prior to start of study treatment will receive a 4-week run-in treatment with abiraterone to confirm refractoriness to abiraterone treatment Additional inclusion criteria for patients in CCS1477 plus enzalutamide combination arm:
  • Patients must have previously progressed on enzalutamide treatment
  • Patients whose last dose of enzalutamide is greater than 6 months prior to start of study treatment will receive a 4-week run-in treatment with enzalutamide to confirm refractoriness to enzalutamide treatment Additional inclusion criteria for patients in mutation arm:
  • Advanced solid tumour with identification of markers which may indicate potential for response to p300/CBP inhibition. Markers include loss of function mutations in CREBBP, EP300 or ARID1A, MYC gene amplifications or rearrangements and androgen receptor (AR) gene amplifications or over-expression. Exclusion Criteria:
  • Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
  • Radiotherapy with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks of the first dose of study treatment
  • Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
  • Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  • Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
  • Statins; patients should discontinue statins prior to starting study treatment
  • Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of starting study treatment
  • Any evidence of severe or uncontrolled systemic diseases
  • Any known uncontrolled inter-current illness
  • QTcF prolongation (> 480 msec).
  • Primary brain tumours or known or suspected brain metastases. Additional exclusion criteria for patients in CCS1477 plus abiraterone combination arm:
  • Clinically significant cardiac abnormalities Additional

Exclusion Criteria:

  • Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
  • Radiotherapy with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks of the first dose of study treatment
  • Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
  • Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  • Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
  • Statins; patients should discontinue statins prior to starting study treatment
  • Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of starting study treatment
  • Any evidence of severe or uncontrolled systemic diseases
  • Any known uncontrolled inter-current illness
  • QTcF prolongation (> 480 msec).
  • Primary brain tumours or known or suspected brain metastases. Additional exclusion criteria for patients in CCS1477 plus abiraterone combination arm:
  • Clinically significant cardiac abnormalities Additional exclusion criteria for patients in CCS1477 plus enzalutamide combination arm:
  • History of seizures or other predisposing factors
  • Use of substrates with a narrow therapeutic index metabolised by CYP2C9 or CYP2C19 within 2 weeks of the first dose of study treatment
  • Clinically significant cardiac abnormalities

View trial on ClinicalTrials.gov


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

Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s): is One-sided Salvage Extended Lymph Node Dissection Enough


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04271579

Sponsor: Martini-Klinik am UKE GmbH

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • Patients in good general condition with life expectancy> 10 years
  • Hormone-sensitive prostate cancer recurrence after radical prostatectomy (patients with status post salvage prostatectomy may be included; salvage radiotherapy for prostate fossa and / or pelvic lymph drainage after radical prostatectomy is not an exclusion criterion)
  • Unilateral detection of ≤ 3 PSMA PET positive lymph node metastases in the pelvis (up ot origin of the inferior mesenteric artery)
  • PSA at the time of PSMA PET imaging <4 ng / ml

Exclusion Criteria:

  • Contraindication for surgery or bilateral salvage lymph node dissection
  • Suspected prostate cancer recurrence in the prostate fossa (local recurrence) or extrapelvic metastasis on PSMA PET imaging
  • Date of PSMA PET examination > 4 months prior to salvage lymph node dissection
  • Hormone therapy within 6 months prior to study enrollment

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 AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04221542

Sponsor: Amgen

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Parts 1, 2, and 5: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and/or enzalutamide, apalutamide, or darolutamide) and have failed at least 1 (but not more than 2) taxane regimens including for metastatic hormone-sensitive prostate cancer (mHSPC) (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Any NHT that has been administered and has been stopped for reasons other than progression will not be counted as an additional line of treatment. 1. Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease. 2. Dose expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.
  • Part 3: Participants with histologically or cytologically confirmed mCRPC who are refractory to a NHT (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) given in any disease setting and who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen.
  • Parts 4A and 4B: 1. Participants with histologically or cytologically confirmed mCRPC who have received no or 1/2 prior NHT (given in any disease setting depending on the part), and no or 1 taxane (given for hormone sensitive prostate cancer). 2. Dose-expansion phase: at least 1 prior NHT must have been given; 0-1 prior PARP inhibitors are acceptable. 3. 4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible). Participants may have had exposure to up to 2 NHTs with a similar mechanism of action (apalutamide, enzalutamide or darolutamide) in the non-mCRPC and mCRPC setting. 4. 4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide/apalutamide or daralutamide are not eligible).
  • All parts:
  • Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.
  • Total serum testosterone <= 50 ng/dL or 1.7 nmol/L.
  • Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria: 1. PSA level >= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart. 2. nodal or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with PCGW3 modifications. 3. appearance of 2 or more new lesions in bone scan.
  • Eastern Cooperative Oncology Group performance status of 0-1.
  • Adequate organ function, defined as follows: 1. Hematological function: 1. absolute neutrophil count >= 1 x 10^9/L (without growth factor support within 7 days from screening assessment). 2. platelet count >= 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment). 3. hemoglobin >= 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment). 2. Renal function: 1. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation >= 30 ml/min/1.73 m^2. 3. Hepatic function: 1. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (or < 5 x ULN for participants with liver involvement). 2. total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for participants with liver metastases). 4. Cardiac function: 1. left ventricular ejection fraction > 50% (2-D transthoracic echocardiogram [ECHO] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available). 2. Baseline electrocardiogram (ECG) QTcF <= 470 msec (average of triplicate values).

Exclusion Criteria:

  • Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.
  • Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).
  • Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
  • Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration.
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
  • History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation.
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.
  • Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)/GnRH analogue (agonist/antagonist). Participants on a stable bisphosphonate or denosumab regimen for >= 30 days prior to enrollment are eligible.
  • Prior PSMA radionuclide therapy within 2 months prior to AMG 509 unless participant received < 2 cycles (Note: a participant cannot have received PSMA radionuclide therapy < 35 days prior to enrollment if 1 cycle was given). Parts 3 and 4: prior PSMA radionuclide therapy is prohibited.

View trial on ClinicalTrials.gov


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

PSMA-PET Registry for Recurrent Prostate Cancer


Condition: Recurrent Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03718260

Sponsor: Lawson Health Research Institute

Eligibility:

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

Inclusion Criteria:

  1. Written informed consent obtained
  2. Male, Age ≥ 18 years
  3. Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer. Unless PET/CT requested as part of Cohort
  4. Suspected persistent or recurrent disease defined as one of the following (unless PET/CT requested as part of Cohort 7):
  5. High risk disease at the time of radical prostatectomy characterized by pathologically involved node(s) or persistently detectable PSA (>0.1ng/ml) within 3 months post-surgery
  6. Primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following: i. Following primary radical prostatectomy, BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured at >0.1 ng/ml ii. Following primary radiotherapy for localized disease, BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured greater than the nadir PSA + 2.0 ng/ml
  7. Patient scenario falls into one of the 7 pre-defined cohorts. When patient scenario falls outside cohorts 1-6 participation in the Registry must be approved through the established CCO adjudication process for Cohort
  8. Karnofsky performance status 70 or better (ECOG 0, 1).
  9. If PSA >10 mg/mL, conventional imaging consisting of bone scan and abdo-pelvic CT scan within 3 months of registration that is either equivocal, negative (no lesions) or positive for oligometastatic disease (4 or fewer unequivocal lesions identified).

Exclusion Criteria:

  1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
  2. Prior PSMA PET scan within 6 months of enrollment.
  3. Patient cannot lie still for at least 60 minutes or comply with imaging.
  4. Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.

View trial on ClinicalTrials.gov


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

A Multi-arm, Phase 2 Study to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation AR-Directed Therapy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03725761

Sponsor: University of Wisconsin, Madison

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Documented histological or cytological evidence of adenocarcinoma of the prostate
  • Documented metastatic disease on bone scan and/or CT scans
  • Currently receiving enzalutamide, darolutamide, apalutamide and/or abiraterone. Subjects who have received combination enzalutamide/abiraterone or combination apalutamide/abiraterone as part of clinical trials are allowed but will need to be receiving only a single agent ARSI at the time of study enrollment. Subjects who have received any other therapeutic investigational product directed towards the AR or androgen biosynthesis are allowed. Prior treatment with first-generation AR antagonists (i.e., bicalutamide, nilutamide, flutamide) before second generation AR-directed therapy is allowed.
  • Demonstrated disease progression while on enzalutamide, darolutamide, apalutamide, and/or abiraterone. Progressive disease is defined by one or more of the following:
  • A rise in PSA on two successive determinations at least one week apart and PSA level ≥2 ng/mL
  • Soft-tissue progression defined by RECIST 1.1
  • Bone disease progression defined by PCWG2 with ≥2 new lesions on bone scan
  • A minimum serum PSA level of ≥2 ng/mL that is rising based on the PCWG2 criteria
  • ≥18 y ears of age
  • Castrate levels of testosterone (<50 ng/dL [1.74 nmol/L])
  • Undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study treatment start. Subjects on LHRH agonists/antagonists must remain on these agents for the duration of the study
  • ECOG Performance Status of 0-1
  • Normal organ function with acceptable initial laboratory values within 30 days of study treatment start:
  • WBC ≥3000/μl
  • ANC ≥1000/μl
  • Platelet count ≥100,000/μl
  • HGB ≥9 g/dL
  • Adequate hepatic function as evidenced by AST/ALT levels <3X the ULN and bilirubin levels of <2.0 mg/dl.
  • Adequate renal function as evidenced by serum creatinine of <2.0 mg/dL
  • Able to provide written informed consent, or have a legal representative provide written informed consent
  • Subjects must have a previously-acquired biopsy from a metastatic site available
  • Subjects must be willing and able (in the opinion of the treating physician) to undergo one research biopsy for the investigational component of this study
  • Subjects who have partners of child-bearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the treatment period and for 90 days after last dose of IMMU-132. Subjects must also agree to not donate sperm through 90 days following the last dose of IMMU-132.

Exclusion Criteria:

  • Received prior cytotoxic chemotherapy such as docetaxel, cabazitaxel or platinum chemotherapy for metastatic prostate cancer, castration sensitive or castration resistant, within two years prior to study entry. Neoadjuvant chemotherapy is allowed.
  • Completed sipuleucel-T (Provenge ®) treatment within 30 days of study treatment start.
  • Received any therapeutic investigational agent within 2 weeks of study treatment start.
  • Received palliative radiotherapy within 4 weeks of study treatment start.
  • Received herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc.) within 4 weeks of study treatment start or plans to initiate treatment with these products/alternative therapies during the entire duration of the study.
  • Active CNS metastases from prostate cancer. Subjects with treated epidural disease are eligible to enroll. Subjects with treated brain metastases can be included as long as >4 weeks have elapsed since last treatment (radiotherapy or surgery) for brain metastases, the subject is neurologically and radiographically stable, and is not receiving corticosteroids for brain metastases. Subjects with untreated brain metastases are excluded. Brain imaging (CT or MRI) is not required at baseline if brain metastases are not clinically suspected.
  • A history within the last 3 years of another invasive malignancy (excluding non-melanoma skin cancer).
  • A QTcF interval of >470 msec on the initial Screening ECG; if the Screening ECG QTcF interval is >470 msec, then it may be repeated two more times, and if the mean QTcF of the 3 ECGs is ≤470 msec, the subject may be enrolled.
  • A history of clinically significant cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes and second degree or third degree atrioventricular heart block without a permanent pacemaker in place. Subjects with resolved or rate-controlled atrial fibrillation/atrial flutter are allowed.
  • NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction/acute coronary syndrome within the preceding 6 months.
  • Diabetes mellitus with more than 2 episodes of diabetic ketoacidosis in the 12 months preceding study treatment start.
  • Inadequately controlled hypertension (defined as blood pressure >150mmHg systolic and/or >100 mmHg diastolic despite antihypertensive medication) or any history of hypertensive crisis or hypertensive encephalopathy.
  • History of loss of consciousness or transient ischemic attack within 12 months before study treatment start.
  • Known active HIV, Hepatitis B, or Hepatitis C infections.
  • Any other medical, psychiatric, or social condition, including substance abuse, which in the opinion of the Investigator would preclude safe participation in the study.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}