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:

• A diagnosis of prostate cancer must be confirmed by a pathologist's report or tissue sample, or by a clinical history consistent with prostate cancer if no tissue sample is available.
• The cancer must have spread (metastasised) to at least one site, shown on a bone scan or other imaging.
• For participants with hormone-sensitive prostate cancer that has spread (mCSPC): hormone-reducing therapy (ADT) must have been started within the last 134 days. For certain parts of the trial (Cohort 3 only), the cancer must have spread widely — meaning it has reached organs or there are 4 or more bone lesions, with at least one outside the spine or pelvis.
• For participants with prostate cancer that has stopped responding to hormone therapy (mCRPC): ongoing hormone-reducing therapy (ADT) must be part of their treatment plan, unless they have previously had surgical removal of the testicles.
• For mCRPC participants: prior treatment with at least one modern hormone-blocking drug — such as abiraterone, enzalutamide, apalutamide, or darolutamide — is required.
• For mCRPC participants: the cancer must not have progressed during or within 3 months of completing docetaxel chemotherapy when it was given for hormone-sensitive disease.
• For mCRPC participants: disease progression must be shown by a rising PSA above 2.0 ng/ml or new findings on a CT or bone scan.
• Any side effects from previous cancer treatments (including surgery or radiation) must have settled to a mild level (Grade 1 or lower) before joining.
• Participants must be male and aged 18 or older.
• Participants must be in reasonably good general health, rated at ECOG performance status 0, 1, or 2 (confirm with trial site for what this means in practice).
• Blood, liver, and kidney test results must fall within acceptable ranges as determined by the trial site, including sufficient white blood cell count, platelet count, haemoglobin, liver function, kidney function, and blood protein levels (confirm specific values with trial site).
• Sexually active participants and their female partners must agree to use a barrier method of contraception (such as a condom) from enrolment, throughout treatment, and for 4 months after the last dose. If a partner becomes pregnant or suspects pregnancy, the treating doctor must be informed immediately.
• Participants must be able to understand the study information and willing to sign a consent form, and willing to travel to the study site (NIH) for follow-up visits.
• Participants who have previously received immune checkpoint therapy may be considered for enrolment at the lead researcher's discretion.

Who may not be able to join:

• People who have HIV or a weakened immune system due to other immune conditions or diseases that could interfere with treatment.
• People with active autoimmune diseases such as lupus, myasthenia gravis, Goodpasture syndrome, active Grave's disease, Sjögren's syndrome, scleroderma, Addison's disease, or active Hashimoto's thyroiditis. People with a history of autoimmune conditions that have not needed systemic treatment and do not affect vital organs may still be considered.
• People with a serious ongoing medical condition that the trial doctor believes would interfere with completing treatment.
• People currently taking certain medications for urinary symptoms, including finasteride, dutasteride, or natural remedies known to affect PSA levels (such as saw palmetto or phytoestrogens).
• People taking certain medications that interact with specific liver enzymes (CYP3A4 inducers or sensitive CYP2D6 substrates) within 14 days or 5 half-lives before starting the trial, whichever is shorter (confirm with trial site).
• People who have received another experimental treatment within the last 28 days (or 60 days for antibody-drug treatments).
• People who test positive for Hepatitis B or Hepatitis C.
• People with uncontrolled high blood pressure (above 170/105 mmHg).
• People who have received a live vaccine within 30 days before starting the trial. Flu vaccines without live virus and locally approved COVID-19 vaccines are permitted.
• People with mCRPC who have previously received docetaxel chemotherapy for that stage of disease.
• People with mCSPC who did not start abiraterone within 6 weeks of beginning hormone therapy, or who have previously received docetaxel at any stage.
• People with mCSPC whose cancer progressed within 3 months of completing docetaxel.
• People with a known allergy to drugs with a similar composition to the study drugs being used.
• People who have had another active cancer requiring systemic treatment within the last 3 years (non-melanoma skin cancers or early-stage bladder cancer in situ are generally not excluded — confirm with trial site).
• People with active cancer spread to the brain or the area around the spinal cord.
• People with moderate or severe nerve damage in the hands or feet (Grade 2 or higher peripheral neuropathy) at the time of enrolment.

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