Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given their written agreement to take part in the study
• People aged 18 or older
• People whose overall health and ability to carry out daily activities falls within an accepted range, as measured by a standard oncology scale (called ECOG performance status 0–2; confirm with trial site what this means for a specific situation)
• People whose life expectancy is estimated to be more than 6 months
• People who have had prostate cancer confirmed through tissue or cell testing by a laboratory
• People whose recent specialised PET/CT scan using a tracer called 64Cu-SAR-bisPSMA showed that at least one known tumour site absorbed more of the tracer than the liver did
• People whose testosterone levels in the blood are at castrate level (very low, below a specific threshold set by the trial)
• People with prostate cancer that has spread to other parts of the body, is no longer responding to hormone therapy, and has continued to grow despite prior hormone-reducing treatment, AND who also meet one of the following treatment history requirements:
  • For the Dose Escalation part: People who have previously been treated with at least one of enzalutamide, abiraterone, or a similar type of hormone-blocking drug
  • For the Cohort Expansion Main Group: People whose cancer has progressed one or two times after treatment with a second-generation hormone-blocking drug (such as abiraterone, enzalutamide, darolutamide, or apalutamide), where that drug was the most recent treatment received, and who would not be taking that type of drug at the same time as the trial treatment
  • For the Cohort Expansion Concomitant Enzalutamide Group: People whose cancer has progressed only once after treatment with a second-generation hormone-blocking drug other than enzalutamide (such as abiraterone, darolutamide, or apalutamide), where that drug was the most recent treatment received
• People whose cancer is confirmed to be progressing, based on at least one of: rising PSA blood test results on two separate occasions, growth of existing tumours or appearance of new soft-tissue tumours on scans, or new bone lesions on a bone scan
• People who have at least one area of cancer spread visible on a CT, MRI, or bone scan done within 28 days before joining the study
• People who have recovered from serious side effects of previous treatments to an acceptable level (Grade 2 or lower; confirm with trial site)
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (specific thresholds apply; confirm with trial site)
• People living with HIV who are in good health and considered by the treating doctor to have a low risk of HIV-related complications
• People who have a partner who could become pregnant must use an adequate barrier method of contraception

Who may not be able to join:

• People who have had major surgery within the 12 weeks before joining the study
• People who have cancer that has spread to the brain
• People whose prostate cancer has been identified as a specific rare type called small cell or neuroendocrine prostate cancer
• People with a previous diagnosis of leukaemia or a bone marrow condition called Myelodysplastic Syndrome
• People who have been diagnosed with a blood clot in a vein (DVT) or a blood clot in the lungs (pulmonary embolism) within the 4 weeks before joining the study
• People with a severe blockage of the urinary tract that cannot be managed
• People whose scans show areas of cancer growth that do not show up on the 64Cu-SAR-bisPSMA PET/CT scan (this rule does not apply to certain early phases of the trial; confirm with trial site)
• People who have previously received certain types of radioactive treatments within specific time periods before the trial (the exact drugs and timeframes differ depending on which part of the trial a person is joining; confirm with trial site)
• People who have received most types of systemic anti-cancer treatment (such as immunotherapy or biological therapies) within the 4 weeks before starting trial treatment — with some exceptions such as ongoing hormone-reducing therapy or low-dose steroids
• People in the Dose Escalation part who have received chemotherapy within 4 weeks before the first trial treatment
• People in the Cohort Expansion part who have previously received chemotherapy for castration-resistant prostate cancer, or who have received a type of drug called a PARP inhibitor (some exceptions apply for early-stage chemotherapy; confirm with trial site)
• People who have taken part in another clinical trial using an experimental treatment within 4 weeks before joining this study
• People with a known allergy or sensitivity to any component of the trial drugs or similar substances
• People who received a blood transfusion solely to meet the blood count requirements for joining the trial
• People who have cancer spread to the spine that is pressing on or at risk of pressing on the spinal cord
• People with serious ongoing medical conditions such as severe heart failure, a history of a heart condition affecting heart rhythm (called congenital long QT syndrome), uncontrolled infection, active hepatitis B or C, or other significant health conditions that the treating doctor believes would prevent safe participation
• People who have another active cancer that is expected to affect life expectancy or make it difficult to assess the prostate cancer — though people who have been cancer-free for more than 3 years after treatment for a previous cancer, or who have had certain treated skin or bladder cancers, may still be considered
• People whose personal or home situation would create an unacceptable radiation safety risk after receiving treatment (for example, uncontrolled urinary incontinence or living in a high-dependency care setting; confirm with trial site regarding relevant guidelines)
• People for whom external beam radiation therapy is already planned after joining the study (this does not apply to certain early phases of the trial; confirm with trial site)
• People joining the Cohort Expansion Concomitant Enzalutamide Group who have a known allergy to enzalutamide or its ingredients, a history of seizures, a history of loss of consciousness (unless due to a heart-related cause) or a mini-stroke within the past 12 months, or certain conditions that raise the risk of seizures — including a history of brain injury, stroke, brain blood vessel abnormalities, certain brain diseases, brain tumours, uncontrolled high blood pressure, or alcohol withdrawal

Important: Always verify eligibility with the trial site directly before applying.