Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 are willing to give written consent before any study-related procedures begin
• People aged 18 or older
• People who have been diagnosed with prostate cancer (adenocarcinoma type), confirmed by a tissue sample
• People whose prostate cancer has stopped responding to hormone-lowering treatment, shown by rising PSA levels and very low testosterone in the blood
• People whose PSA level is at least 2 ng/mL and has been rising on two separate measurements taken at least two weeks apart
• People who have already been treated with at least one modern hormone-blocking drug (such as abiraterone or enzalutamide) that stopped working, and who have had at least a 2-week break since stopping their most recent prostate cancer treatment
• People enrolling in Cohort 3 must have a specific type of scan (68Ga-PSMA-11 PET) showing a protein called PSMA on their cancer cells, meeting criteria used in a previous study called the VISION trial
• People who have not had chemotherapy for their current stage of prostate cancer (though prior chemotherapy for an earlier stage is allowed)
• People who have had prior non-chemotherapy experimental treatments, provided at least 2 weeks have passed since stopping them
• People with haemoglobin levels of at least 9 g/dL, without needing a blood transfusion in the past 28 days (tested within 30 days before treatment)
• People with adequate white blood cell counts (ANC at least 1.5 x 10⁹/L), tested within 30 days before treatment
• People with adequate platelet counts (at least 100 x 10⁹/L), tested within 30 days before treatment
• People with liver function blood test results within acceptable ranges, tested within 30 days before treatment (higher limits apply if cancer has spread to the liver)
• People with adequate kidney function, confirmed by blood or urine test within 30 days before treatment
• People with a general health/functioning score of 0, 1, or 2 on a standard medical scale (ECOG), meaning they are able to carry out at least some daily activities
• People expected to live at least 16 weeks
• People willing and able to follow the study schedule, including all visits, treatments, and check-ups
• People who have at least one area of cancer that can be measured or tracked using scans (CT, PET, MRI, or bone scan)
• People willing to have a biopsy taken from a cancer that has spread to another part of the body
• Male patients who are sexually active with a partner who could become pregnant must agree to use two reliable forms of contraception during treatment and for 6 months after the last dose

Who may not be able to join:

• People who are involved in planning or running this study
• People who have had another cancer in the past 2 years, unless it was fully treated and there is no sign of it returning (some minor skin cancers and certain early bladder cancers may be exceptions)
• People still experiencing significant side effects (grade 2 or higher on a standard medical scale) from previous cancer treatment, not including hair loss
• People with brain cancer spread that is causing symptoms, or people with spinal cord compression that has not been definitively treated and stable for at least 28 days
• People taking corticosteroid medication (such as prednisone) at a dose higher than 10 mg per day
• People planning to receive another systemic cancer treatment at the same time (hormone-suppressing injections are allowed)
• People currently taking the blood thinner warfarin (other types of blood thinners may be allowed after discussion with the lead doctor)
• People who have had major surgery within 2 weeks before starting the study, or who have not yet recovered from surgery
• People with serious uncontrolled medical conditions, such as uncontrolled irregular heartbeat, uncontrolled seizures, high blood pressure of 165/100 or above, history of stroke, unstable spinal cord compression, a major vein blockage in the chest, significant lung disease, or a psychiatric condition that would prevent giving informed consent
• People with a known allergy to testosterone cypionate, etoposide, carboplatin, or any ingredients in these medications
• People with active hepatitis B or C infection
• People with serious or unstable existing medical or psychiatric conditions that could affect their safety or ability to participate
• People with personal, family, social, or geographical circumstances that could make it difficult to follow the study schedule
• People whose cancer, in the treating doctor's judgement, would make testosterone treatment risky (for example, cancer near the thigh bone raising fracture concerns, cancer near the spine raising spinal cord compression concerns, or cancer blocking urinary passages)
• People experiencing pain from their prostate cancer (due to the risk of a pain flare from testosterone used in the study)
• People whose tumour is blocking the urinary passage and requires a catheter to urinate, where that blockage is caused by the cancer (catheters needed for other non-cancer reasons are generally acceptable)
• People with a history of a blood clot in a vein or the lungs within the past 5 years who are not currently on blood-thinning medication
• People with severe heart failure (Class III or IV on a standard heart failure scale) or a heart attack within the past 5 years

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