Phase 3 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:

General eligibility (all participants):

• People who are at least 18 years old
• People who have been confirmed by tissue testing to have prostate adenocarcinoma, or who are strongly suspected to have prostate cancer with a plan to confirm this before joining a treatment comparison
• People whose cancer has spread (metastasised) to the bones, to lymph nodes outside the pelvis, or to internal organs, as confirmed by CT/MRI and bone or PET scans (certain lymph node-only cases must meet specific size and location requirements — confirm with trial site)
• People whose cancer is either newly diagnosed and already spread (de novo), or has returned (relapsed) and is still responding to hormone treatment, provided all hormone treatments were completed at least 2 years before joining a treatment comparison and total hormone therapy did not exceed 3 years
• People who have started, or who are planned to start, long-term hormone therapy (ADT) for at least 2 years
• People with a general health/activity level rated 0–2 on the WHO scale, or rated 3 but expected to improve once hormone therapy begins (confirm with trial site)
• People who are willing and able to follow the trial treatment plan
• People who have signed the trial consent form

For the SABR (targeted radiation) comparison:

• People who meet all the general eligibility criteria above
• People with a tissue-confirmed diagnosis of prostate adenocarcinoma
• People with newly diagnosed (de novo) metastatic disease that has 1–5 metastatic spots in bone and/or lymph nodes outside the pelvis, with no spread to internal organs, and where a clinician has determined the spots are technically suitable for targeted radiation
• People who have already started hormone therapy (ADT), with the time between starting ADT and joining this comparison being 12 weeks or less
• People with a WHO health/activity level rated 0–2
• People who have signed the consent form for this specific comparison

For the 177Lu-PSMA-617 (radioligand therapy) comparison:

• People who meet all the general eligibility criteria above
• People with a tissue-confirmed diagnosis of prostate adenocarcinoma
• People whose disease has been assessed as not suitable for the SABR comparison (as defined by the trial)
• People whose recent blood tests (within 4 weeks before joining) show the bone marrow, liver, and kidneys are functioning adequately — this includes specific counts for white blood cells, platelets, haemoglobin, liver enzymes, bilirubin, kidney filtration rate, and albumin levels (confirm specific thresholds with trial site)
• People who have already started hormone therapy (ADT), with the time between starting ADT and joining this comparison being 12 weeks or less
• People with relapsed disease where prior hormone therapy was stopped at least 2 years before joining, did not exceed 3 years total, and where the cancer did not progress within 12 months of finishing that earlier hormone therapy
• People with a WHO health/activity level rated 0–2
• People who have signed the consent form for this specific comparison

Who may not be able to join:

General exclusions (all participants):

• People whose cancer is confirmed or clearly appears to be a type called small cell carcinoma
• People whose cancer has spread to the brain or the lining of the brain/spinal cord
• People who have had another active cancer (one that is still progressing or required treatment in the past 36 months), other than prostate cancer — with exceptions for certain low-risk bladder cancers, non-melanoma skin cancers, or cancers considered fully cured with very low chance of return
• People with other medical conditions that, in the treating doctor's opinion, make long-term hormone therapy or the trial treatments unsafe or unsuitable

Additional exclusions for the SABR comparison:

• People whose prostate cancer has returned (relapsed) rather than being newly diagnosed
• People who have already had major treatment to the prostate, such as surgery or radiotherapy
• People whose cancer has spread to the brain
• People who have already received treatment to a metastatic site (such as radiotherapy, surgery, or ablation)
• People with serious or worsening nerve problems requiring emergency surgery or radiation within 24 hours (for example, spinal cord compression)
• People with conditions that, in the clinician's judgement, prevent the planning or delivery of radiotherapy — such as certain bowel conditions, connective tissue disorders, or lung scarring (confirm with trial site)
• People with another active cancer within the past 36 months (other than prostate cancer)

Additional exclusions for the 177Lu-PSMA-617 comparison:

• People who have previously received certain bone-targeting radioactive treatments (strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223)
• People who have previously received any PSMA-targeted radioligand therapy
• People with spinal cord compression that is causing symptoms, or where imaging suggests cord compression is about to occur
• People with any condition that prevents them from lying with their arms raised (as required for the treatment procedure)
• People with bladder blockage or urinary leakage that cannot be managed or controlled
• People taking part in the imaging sub-study only: people with a reason they cannot have an MRI scan, such as having a non-MRI-compatible pacemaker

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