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 are at least 18 years old
• People whose prostate cancer has been confirmed by a tissue sample (biopsy) showing a specific type called adenocarcinoma
• People who are reasonably physically active and able to care for themselves — scoring 2 or below on a standard activity scale used by doctors (confirm with trial site)
• People who are receiving ongoing hormone-lowering treatment, either through surgical removal of the testicles or through regular hormone-blocking injections or implants
• People whose blood testosterone level has been confirmed as very low (below 50 ng/dl)
• People whose cancer has spread to other parts of the body, confirmed by a CT scan or bone scan
• People whose cancer continued to grow while being treated with a drug called abiraterone acetate combined with hormone therapy — shown either by rising PSA levels on two separate tests at least one week apart, or by visible growth on scans
• People with a PSA level of at least 1.0 ng/mL at the time of screening
• People who have soft tissue tumours that can be safely biopsied must agree to provide tissue samples before and during the trial
• People who have not previously been treated with enzalutamide, apalutamide, darolutamide, or similar investigational hormone-targeting drugs
• People who have previously received testosterone treatment
• People who received up to 6 doses of a chemotherapy drug called docetaxel for hormone-sensitive prostate cancer (before the cancer became resistant to hormone therapy)
• People who previously received treatments called Provenge vaccine or Radium-223 (Xofigo), as long as the last dose was more than 4 weeks ago
• People who have stopped taking abiraterone for at least 2 weeks before starting the trial
• People who have attempted to reduce or stop taking prednisone (a steroid) before starting the trial — those who cannot stop completely due to symptoms may continue on the lowest dose achieved
• People whose liver function blood test results fall within acceptable ranges (confirm specific values with trial site)
• People whose kidney function blood test results fall within acceptable ranges (confirm specific values with trial site)
• People whose blood counts — including white blood cells, platelets, and red blood cells — fall within acceptable ranges (confirm specific values with trial site)
• People who have had at least 4 weeks pass since their last radiation or chemotherapy treatment
• People who are able to understand the study and are willing to sign a consent form

Who may not be able to join:

• People who are experiencing pain from their prostate cancer spreading, that requires pain medication
• People who score 3 or higher on the standard doctor-used activity scale, meaning they have significant physical limitations
• People who have previously been treated with enzalutamide
• People who have received chemotherapy with docetaxel or cabazitaxel specifically for castration-resistant prostate cancer (the stage where cancer grows despite very low testosterone)
• People who need to use a self-inserted tube (catheter) to urinate due to a blockage caused by prostate cancer or an enlarged prostate — note that people who already have a permanently placed catheter may still be eligible (confirm with trial site)
• People whose cancer has spread in ways that the trial doctor believes would make testosterone treatment risky — for example, cancer near a bone that could fracture, severe spinal spread, or extensive spread to the liver
• People with serious ongoing medical or psychiatric conditions that could affect their safety or their ability to participate
• People with an active uncontrolled infection, or a known history of HIV/AIDS, hepatitis B, or hepatitis C
• People with any condition or mental impairment that affects their ability to give informed consent or safely follow the study requirements
• People currently taking blood-thinning medications called warfarin, rivaroxaban, or apixaban — although people who are able to switch to a different blood thinner called enoxaparin before starting the trial may be eligible (confirm with trial site)
• People who have had a blood clot event in the last 12 months and are not currently on blood-thinning medication
• People with a red blood cell level (haematocrit) above 51%, untreated severe sleep apnoea, or poorly controlled heart failure
• People who are allergic to sesame seed oil or cottonseed oil
• People who have had major surgery requiring general anaesthesia within 3 weeks before screening, or who have not fully recovered from a previous surgery — note that minor procedures done under local anaesthesia may be acceptable (confirm with trial site)

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