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 have been diagnosed with prostate cancer that is confirmed by a lab report to be the type called adenocarcinoma (or a mixed type where more than half is adenocarcinoma).
• People who have cancer that has spread to the bones, shown by at least one spot on a bone scan done within 2 months of the screening visit.
• People whose prostate cancer has continued to grow or spread despite having very low testosterone levels (through surgery or hormone-blocking treatment), shown by either two rising PSA blood test results or new spots appearing on a bone scan.
• People with a PSA blood test result of 2.0 or higher.
• People who have been taking bone-strengthening medication (either zoledronic acid or denosumab) for at least 4 weeks before joining, and are able to continue taking it throughout the trial.
• People who are generally well enough to carry out light activity and care for themselves (confirmed with trial site using a standard medical rating scale).
• People whose cancer is causing no symptoms, or only mild symptoms that do not require strong pain medication (opioids).
• People who have previously been treated with no more than one of the newer hormone-blocking drugs for prostate cancer (such as abiraterone, enzalutamide, darolutamide, or apalutamide), though prior treatment is not required to be eligible.
• People who may have previously had chemotherapy for an earlier stage of prostate cancer, as long as it was completed at least 12 months before joining the trial.
• People whose blood test results show that bone marrow, kidney, and liver function are within acceptable ranges (confirm specific values with trial site).
• People with no history of another cancer in the past 5 years, except for certain treated skin cancers (basal cell or squamous cell carcinoma).
• People who have tissue samples available for genetic analysis — this may be from a previous biopsy or prostate surgery, or a new biopsy may be taken during screening.

Who may not be able to join:

• People whose cancer has spread to internal organs such as the lungs, liver, or brain.
• People who have compression of the spinal cord, a bone that is close to breaking, or any condition that is likely to need radiation or steroid treatment for pain during the trial.
• People who have previously had chemotherapy for advanced prostate cancer that no longer responds to hormone treatment, or any chemotherapy within the 12 months before joining.
• People who have had radiation therapy (external beam or internal) within 28 days before joining.
• People who have received certain radioactive treatments targeting bone metastases within the past 24 weeks.
• People currently using strong opioid pain medications (such as oxycodone, morphine, or methadone) for cancer-related pain (note: weaker pain medications such as codeine or tramadol are permitted).
• People who have taken part in another experimental drug study within 4 weeks of starting treatment.
• People who still have their prostate and are also experiencing urinary problems (including those caused by a non-cancerous enlarged prostate).
• People currently taking the blood-thinning medication warfarin (other blood thinners such as rivaroxaban, dabigatran, or apixaban are permitted).
• People experiencing symptoms from cancer that has spread to lymph nodes, such as swelling of the legs, scrotum, or penis.
• People with serious, poorly controlled health conditions such as uncontrolled diabetes, heart failure, severe lung disease, certain bowel conditions, irregular heart rhythms, a heart attack within the past 12 months, blood clots, or a psychiatric condition that would prevent giving informed consent.
• People whose cancer, in the opinion of the treating doctor, would make testosterone-based treatment too risky — for example, due to certain bone metastases that raise the risk of fracture or spinal cord compression.

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