Actively Recruiting
Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)
Led by Case Comprehensive Cancer Center · Updated on 2025-08-27
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for metastatic castrate-resistant prostate cancer (mCRPC) in participants whose cancer no longer responds to hormone therapy and docetaxel, and who have prostate-specific membrane antigen (PSMA) positive tumors. This phase 2 trial aims to determine which treatment works best among options including cabazitaxel combined with carboplatin versus 177Lu-PSMA-617. The study addresses the challenge of finding effective therapies as mCRPC typically has a poor prognosis with limited survival despite available treatments. Participants will be randomly assigned to receive either cabazitaxel with carboplatin or 177Lu-PSMA-617. The cabazitaxel and carboplatin regimen involves intravenous infusions every three weeks for up to 10 cycles or until disease progression or unacceptable side effects occur. The 177Lu-PSMA-617 treatment is given intravenously every six weeks for up to 6 cycles or until progression or toxicity. Both treatments are investigational in this setting and administered under medical supervision. During the study, participants will undergo evaluations including PSA blood tests to measure treatment response at baseline and 12 weeks after starting treatment. Additional outcomes monitored include progression-free survival and time until the need for next cancer therapy. Researchers will also assess safety and tolerability. The study duration varies by participant depending on treatment cycles and disease progression, with regular clinical assessments to monitor health and treatment effects throughout the trial period.
CONDITIONS
Brief Title
Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic castrate-resistant prostate cancer previously treated with an androgen receptor pathway inhibitor
- PSMA-positive 18F-rhPSMA-7.3 imaging within 12 weeks showing at least one site with SUVmax 610, or specific combinations of metastases or mutations
- Age over 18 years
- ECOG performance status of 0 to 2
- Adequate organ and marrow function as defined by blood counts, liver and kidney function tests
- Stable dose of bisphosphonates or approved bone-targeting therapy for at least 14 days before treatment
- Agreement to use highly effective contraception methods if of child-producing potential
- Ability to understand and willingness to sign informed consent
- Members of all races and ethnic groups are eligible
You will not qualify if you...
- Evidence of hormone-sensitive prostate cancer
- Evidence of small cell prostate cancer
- Receiving other investigational agents
- Diagnosis of another clinically significant cancer within the last 2 years except certain non-melanoma skin cancers or noninvasive malignancies
- Known or suspected allergy to cabazitaxel, carboplatin, or 177Lu-PSMA-617 components
- Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Prior treatment toxicities not resolved to grade 2 or less
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 weeks or until disease progression or unacceptable toxicity
Participants receive either cabazitaxel with carboplatin or 177Lu-PSMA-617 as active treatment for metastatic castrate-resistant prostate cancer.
Cabazitaxel and carboplatin every 3 weeks for up to 10 cycles; or 177Lu-PSMA-617 every 6 weeks for up to 6 cycles
Trial Site Locations
Total: 1 location
1
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
P
Pedro Barata, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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