Phase 2 Prostate Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with prostate cancer that has spread to other parts of the body, is no longer responding to hormone therapy (castrate-resistant), and has previously been treated with a specific type of hormone-blocking medication called an androgen receptor pathway inhibitor. A pathology report confirming the diagnosis is required at enrollment.
- People whose cancer shows up strongly on a specific type of PSMA scan (called an 18F-rhPSMA-7.3 scan, done within 12 weeks of starting the trial), with at least one area of cancer showing a high uptake value, AND whose cancer meets at least one of these additional features: lower overall PSMA uptake in some areas, one or more metastases in organs (such as the liver or lungs), five or more bone metastases — OR has two of the following gene changes in the cancer: TP53, PTEN, or RB1 mutations (confirm with trial site).
- People aged 18 or older.
- People who are reasonably well and able to carry out daily activities, based on a standard medical scale that rates physical functioning from 0 (fully active) to 2 (up and about more than half of waking hours).
- People whose blood counts, liver function, kidney function, and protein levels meet specific minimum health thresholds as measured by blood tests at screening — including sufficient white blood cells, platelets, haemoglobin, liver enzymes, kidney filtration rate, and albumin levels.
- People who are already taking bone-strengthening medications (such as bisphosphonates or denosumab) and have been on a stable dose for at least 14 days before the trial begins.
- People who are capable of fathering a child and who agree to use effective contraception (such as a condom with spermicide) during the trial and for 3 months after the last dose, and who agree not to donate sperm during this time. Partners of participants must also use approved birth control methods.
- People who are able to understand the trial information and are willing to sign a written consent form.
- People of all racial and ethnic backgrounds are eligible.
Who may not be able to join:
- People whose prostate cancer is still responding to hormone therapy (hormone-sensitive prostate cancer).
- People who have a type of prostate cancer called small cell prostate cancer.
- People who are currently taking part in another clinical trial involving an experimental treatment.
- People who have been diagnosed with another significant cancer in the past 2 years — except for certain treated skin cancers or early-stage bladder or other non-invasive cancers, as assessed by the trial doctor.
- People with known serious allergic reactions to any of the trial medications: cabazitaxel, carboplatin, or 177Lu-PSMA-617.
- People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable chest pain, irregular heart rhythm, or mental health or personal circumstances that the trial doctor believes would make it difficult to safely participate.
- People who still have significant side effects (grade 3 or higher on a standard medical scale) from previous cancer treatments that have not yet recovered to a mild level.
Note: People who previously had brain or central nervous system metastases that have already been treated may still be considered eligible (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Pedro Barata, MD, MSc, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Institute
Phone: 216-262-1214
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
PSA response rate as assessed by the change in PSA ratio
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.