Phase 2 Prostate Cancer Trial, Recruiting NCT06738303 Sponsor: Case Comprehensive Cancer Center Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06738303
Recruiting Phase 2

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
14 July 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

PSA response rate as assessed by the change in PSA ratio

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov