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

NCT06738303 | Recruiting Phase 2 DMC

• 1 other identifier: CASE13824
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer

Keywords

Cabazitaxel; Lu-PSMA-617; Carboplatin

Outcome Measures

Primary Outcomes (1)

• PSA response rate as assessed by the change in PSA ratio

  PSA decline of ≥50% (PSA50) at 12 weeks. PSA decline will be measured by obtaining the ratio of PSA obtained on cycle 5 day 1 to baseline PSA obtained cycle 1 day 1.

  Baseline, 12 weeks post intervention

Secondary Outcomes (2)

• Progression Free Survival

  Upto 26 weeks

• Time to next systemic therapy

  Cycle 1 day1(each cycle will be 6 weeks upto 10 cycles) to the first day of subsequent systemic cancer-directed therapy

Study Arms (2)

Arm 1: Cabazitaxel and carboplatin

EXPERIMENTAL

Cabazitaxel: Participants will receive cabazitaxel 20 mg/m2 as a one-hour intravenous infusion every three weeks for a total of 10 cycles or until disease progression, unacceptable toxicity. Carboplatin: Participants will receive carboplatin AUC 4 mg/mL/min every three weeks for a total of 10 cycles or until disease progression, unacceptable toxicity

Drug: Cabazitaxel and carboplatin

Arm 2: Lu-PSMA-617

EXPERIMENTAL

Participants will receive 177Lu-PSMA-617 7.4 GBq IV on Day 1 (+/-1 week) of each 6-week cycle for up to 6 cycles or until disease progression, unacceptable toxicity

Drug: Lu-PSMA-617

Interventions

Cabazitaxel and carboplatin DRUG

Given IV

Arm 1: Cabazitaxel and carboplatin

Lu-PSMA-617 DRUG

Given IV

Also known as: Pluvicto

Arm 2: Lu-PSMA-617

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically or cytologically confirmed metastatic castrate-resistant prostate cancer that has previously been treated with an androgen receptor pathway inhibitor. Prior docetaxel exposure is recommended but not mandatory. Tissue is not mandatory, but a pathologic report is required at time of enrollment.
• Participants must have a PSMA-positive 18F-rhPSMA-7.3 performed within 12 weeks from C1D1 with ≥1 site with SUVmax ≥10) mCRPC with progression on prior novel hormonal agent to include at least one of the following:
• PSMA SUV mean \<10
• ≥1 visceral metastasis
• ≥5 bone metastases
• OR two of the following
• TP53
• PTEN
• RB1 mutation.
• Age \> 18 years.
• ECOG performance status of 0 to 2.
• Subjects must have adequate organ and marrow function as defined below to be suitable for the randomized treatment outlined in this:
• Absolute neutrophil count \>1000/μL; platelet count \>90 000/μL; hemoglobin \>8.5 g/dL) at screening.
• Note: Subjects must not have received any growth factors within 7 days or blood transfusions within 14 days prior to the hematologic laboratory values obtained at screening).
• Total bilirubin (TBIL) \<2.5 × the upper limit of normal (ULN) at screening, except subjects with documented Gilbert syndrome who must have a TBIL \<3 mg/dL

You may not qualify if:

• Evidence of hormone-sensitive prostate cancer (HSPC)
• Evidence of small cell prostate cancer
• Subjects receiving any other investigational agents.
• Diagnosis of another clinically significant malignancy within the previous 2 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or noninvasive malignancies, as determined by the PI or Co-PI.
• Subjects with brain metastases/central nervous system (CNS) disease that are treated prior to enrollment will be allowed in this clinical trial.
• Known or suspected significant hypersensitivity to any components of the formulation used for Cabazitaxel, carboplatin or 177Lu-PSMA-617.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations considered by the Investigator to limit compliance with study requirements.
• Prior treatment toxicities not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; Carboplatin; Pluvicto

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Pedro Barata, MD, MSc

  Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Barata, MD, MSc

CONTACT

216-262-1214; Pedro.Barata@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: July 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)