Recruiting
Phase 2

PSMA Positive Treatment

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06738303

Conditions

Metastatic Prostate Cancer

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Cabazitaxel and carboplatin

Lu-PSMA-617

Study Details

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

Study ID

NCT06738303

Start date

Jul 14, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed adenocarcinoma of prostate
  • Evidence of 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.
  • Patients must have a PSMA-positive 18F-rhPSMA-7.3 performed within 12 weeks from C1D1 with ≥1 site with SUVmax ≥10. An alternative PSMA PET tracer is permitted at baseline if performed within 8 weeks prior to randomization.
  • Eligible patients have evidence of mCRPC who have progressed on prior novel hormonal agent(s) to include at least one of the following:

  • Baseline PSMA SUVmean <10 OR
  • ≥1 visceral metastasis OR
  • ≥5 bone metastases OR one of the following (using Next Generation Sequencing on file within 5 years)
  • TP53
  • PTEN
  • mutation.
  • Age > 18 years.
  • ECOG performance status of 0 to 2.
  • Participants 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: Participants 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 participants with documented Gilbert syndrome who must have a TBIL <3 mg/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 ULN at screening
  • Creatinine clearance ≥40 mL/min and/or estimated glomerular filtration rate (eGFR) ≥30
  • Albumin >30 g/L (3.0 g/dL) at screening
  • Participants receiving bisphosphonates or other approved bone-targeting therapy (e.g., denosumab) must be on a stable dose for at least 14 days before the start of study treatment.
  • Participants of child-producing potential agree to use highly effective contraceptive methods (i.e., barrier contraception measures such as a male condom with spermicide during intercourse) and avoid sperm donation during the study treatment and for 3 months after the last dose of study treatment. A man is considered to be of child-producing potential, unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. Partners of patients must also practice approved forms of birth control
  • Participants must have the ability to understand and the willingness to sign a written informed consent form (ICF).
  • Members of all races and ethnic groups are eligible for this trial

Exclusion Criteria:

  • Evidence of hormone-sensitive prostate cancer (HSPC)
  • Evidence of small cell prostate cancer
  • Participants 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.
  • Participants 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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Cabazitaxel and carboplatin

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

experimental: Arm 2: Lu-PSMA-617

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

Interventions

Cabazitaxel and carboplatin

Given IV

Lu-PSMA-617

Given IV

Primary outcome measure

  • PSA response rate as assessed by the change in PSA ratio [ Time Frame: Baseline, 12 weeks post intervention ]

Central Contacts and Locations

Central contacts

Pedro Barata, MD, MSc

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

Locations

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

Recruiting

Cleveland, Ohio, United States, 44106

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Cabazitaxel
  • Lu-PSMA-617
  • Carboplatin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-14.