Actively Recruiting

Phase 2
Age: 19Years +
All Genders
NCT06738303

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

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

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
Not 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer | DecenTrialz