Actively Recruiting
Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer
Led by Case Comprehensive Cancer Center · Updated on 2025-08-27
44
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.
CONDITIONS
Official 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 scan within 12 weeks from treatment start with at least one site having SUVmax ≥10 mCRPC with progression on prior hormonal agent including specified metastasis or mutations
- Age over 18 years
- ECOG performance status of 0 to 2
- Adequate organ and marrow function including specific blood counts, liver enzymes, kidney function, and albumin levels
- Stable dose of bisphosphonates or bone-targeting therapy for at least 14 days before treatment
- Agreement to use highly effective contraception during and for 3 months after treatment if of child-producing potential
- Ability to understand and willingness to sign informed consent
- All races and ethnic groups eligible
You will not qualify if you...
- Evidence of hormone-sensitive prostate cancer
- Evidence of small cell prostate cancer
- Receiving any other investigational agents
- Diagnosis of another significant malignancy within past 2 years except certain treated skin or urothelial cancers
- Known or suspected allergy to components of cabazitaxel, carboplatin, or 177Lu-PSMA-617
- Uncontrolled intercurrent illness such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance
- Prior treatment toxicities not resolved to Grade 2 or lower according to NCI CTCAE Version 5.0
- Brain metastases or CNS disease are allowed if treated prior to enrollment
AI-Screening
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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
CONTACT
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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