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:

• People who have signed a written consent form before any trial procedures begin (a trusted representative — not the trial doctor or sponsor — may sign on their behalf if they are physically unable to do so)
• People aged 18 or older
• People whose doctor estimates they have a life expectancy of more than 6 months
• People with a general health and activity level that falls within a certain range, as measured by a standard medical scale (ECOG score of 2 or below)
• Men who have been confirmed through tissue or cell testing to have prostate cancer of the adenocarcinoma type
• Men whose prostate cancer had already spread to other parts of the body at the time of first diagnosis, before any treatment began (recent imaging may be accepted if earlier imaging is unavailable)
• Men whose cancer can be measured or assessed through imaging, including bone involvement that meets specific assessment guidelines — cases where bone spread is uncertain are not eligible
• Men who have had a specific type of nuclear medicine scan (68Ga-PSMA-11 PET/CT) performed within 4 weeks before joining the trial — both positive and negative scan results may be eligible
• Men who have been receiving standard prostate cancer treatment for between 6 and 8 months and are still currently on it, consisting of either: hormone therapy (ADT) plus a specific type of hormone-blocking drug (such as abiraterone, apalutamide, or enzalutamide), with or without radiotherapy; or hormone therapy plus chemotherapy (docetaxel, which must have stopped at least 4 weeks before joining) plus a hormone-blocking drug (such as abiraterone or darolutamide), with or without radiotherapy — any radiotherapy must not have been PSMA-based and must have finished at least 4 weeks before joining
• Men whose PSA level (a prostate cancer marker in the blood) is stable or going down, not rising
• Men whose PSA level is 0.2 ng/mL or higher at the 6-to-8-month point after starting treatment
• Men whose testosterone level is below a certain low threshold, consistent with hormone therapy working as expected
• Men whose blood counts, liver function, and kidney function meet minimum levels required for the trial treatment to be given safely (confirm specific values with the trial site)
• Sexually active men with female partners who could become pregnant, or whose partner is pregnant, who agree to use a condom plus another effective contraceptive method during the trial and for up to 14 weeks after treatment ends
• People who are covered by the social security system or have equivalent private health insurance as required under local regulations
• People who are willing and able to follow all trial requirements, including attending appointments and completing follow-up visits

Who may not be able to join:

• People whose cancer shows any signs of getting worse, including a rising PSA, physical symptoms of progression, or changes visible on imaging
• People who have previously had, or are currently receiving, any treatment that targets the PSMA protein (including PSMA-based radioligand therapy)
• People with a known allergy or sensitivity to the trial treatment or similar substances
• People with any condition that would prevent them from safely receiving the treatments used in this trial
• People who have had a stroke, heart attack, severe or unstable chest pain, bypass surgery, or serious heart failure within the 6 months before joining
• People with high blood pressure that is not controlled by medication, confirmed across three consecutive measurements
• People with severe or uncontrolled illness, infection, or other significant health condition
• People whose prostate cancer has been identified as a specific aggressive type called small cell carcinoma
• People who have had another cancer diagnosed within the past 3 years, with the exception of certain successfully treated skin cancers (basal cell or squamous cell)
• People currently taking part in another clinical trial using an investigational treatment, or who have used an investigational treatment within the 28 days before joining
• People who are unable or unwilling to attend the required medical follow-up visits, for any reason including geographic, family, social, or psychological factors
• People who are under legal custody, guardianship, or protective supervision

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