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 18 years of age or older at the time they sign the consent form
• People who are willing and able to give written consent to participate (or have a legal representative do so on their behalf)
• People who have been diagnosed with prostate cancer of a specific type called adenocarcinoma (a different subtype called small cell/neuroendocrine carcinoma would not be eligible)
• People whose prostate cancer has spread (metastasised) to bones or soft tissues, confirmed by scans such as bone scans, CT, MRI, or PET scans at some point in their history
• People whose cancer shows up clearly on a specific type of PET scan called a PSMA scan (18F-DCFPyL), with at least one lesion showing stronger activity than the liver
• People whose cancer has continued to grow despite having very low testosterone levels (under 50 ng/mL), shown either by rising PSA levels or by progression seen on scans — this is called castration-resistant prostate cancer
• People who have previously been treated for at least 4 weeks with one or more specific hormone-blocking medicines, such as abiraterone acetate, enzalutamide, apalutamide, or darolutamide (these may have been used at any stage of the disease)
• People with a general health/activity level rated 0, 1, or 2 on a standard medical scale (ECOG), meaning they are fully active to capable of limited self-care (confirm with trial site)
• People who have 10 or fewer metastases visible on both PSMA and FDG PET scans, and where those metastases are suitable for a targeted radiation treatment called SBRT, with no more than 20% of those lesions being visible only on FDG PET and not PSMA PET
• People with a life expectancy of at least 6 months
• People whose blood and organ function results meet the required levels, including sufficient red blood cells, white blood cells, and platelets, as well as acceptable liver and kidney function (confirm specific values with trial site)
• People who agree to use contraception during treatment and for 120 days after the last dose, and who agree not to donate sperm during that period

Who may not be able to join:

• People whose cancer has spread to the liver or brain (spread to the lungs is permitted)
• People whose cancer has been identified as the small cell or neuroendocrine subtype based on standard tissue testing
• People who have received cancer treatments less than 2 weeks before the first dose of the study treatment, or less than 4 weeks if the prior treatment was an investigational (experimental) therapy — and people who have not yet recovered from side effects of previous treatments
• People who have received any herbal or non-herbal supplements known to lower PSA levels (other than standard hormone therapy or low-dose megestrol for hot flashes)
• People who have had radiotherapy within the 2 weeks before starting the study treatment, or who have not yet fully recovered from radiation-related side effects
• People who have had major surgery and have not fully recovered within the 4 weeks before starting treatment
• People who have had another cancer (other than prostate cancer) that required treatment within the past 24 months — with some exceptions, such as certain non-invasive bladder cancers, non-melanoma skin cancers, or other cancers the treating doctor considers fully resolved and unlikely to affect the study
• People who currently have an active infection requiring antibiotic treatment
• People who have troublesome symptoms from the cancer returning in the original prostate area after a previous attempt at curative treatment (surgery or radiation)
• People with known serious psychiatric conditions or substance use disorders that would make it difficult to take part in the trial
• People who are planning to father children during the study or within 120 days after the last dose of treatment
• People who currently have, or are at risk of, spinal cord compression, or who need urgent radiation therapy for symptom relief

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