RECRUITING

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

Conditions

Metastatic Prostate Cancer Metastatic Castration-resistant Prostate Cancer Cabazitaxel Lu-PSMA-617 Carboplatin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)

Quick Facts

Study Start:2025-07

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06738303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. 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: 1. PSMA SUV mean \<10 2. ≥1 visceral metastasis 3. ≥5 bone metastases 1. TP53 2. PTEN 3. RB1 mutation. 3. Age \> 18 years. 4. ECOG performance status of 0 to 2. 5. 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. * 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 * 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 6. Subjects 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. 7. Subjects 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 participants must also practice approved forms of birth control 8. Subjects must have the ability to understand and the willingness to sign a written informed consent form (ICF). 9. Members of all races and ethnic groups are eligible for this trial.	1. Evidence of hormone-sensitive prostate cancer (HSPC) 2. Evidence of small cell prostate cancer 3. Subjects receiving any other investigational agents. 4. 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. 5. Subjects with brain metastases/central nervous system (CNS) disease that are treated prior to enrollment will be allowed in this clinical trial. 6. Known or suspected significant hypersensitivity to any components of the formulation used for Cabazitaxel, carboplatin or 177Lu-PSMA-617. 7. 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. 8. Prior treatment toxicities not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0

Inclusion Criteria

Exclusion Criteria

1. 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.
2. 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:
1. PSMA SUV mean \<10
2. ≥1 visceral metastasis
3. ≥5 bone metastases
1. TP53
2. PTEN
3. RB1 mutation.
3. Age \> 18 years.
4. ECOG performance status of 0 to 2.
5. 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.
* 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
* 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
6. Subjects 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.
7. Subjects 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 participants must also practice approved forms of birth control
8. Subjects must have the ability to understand and the willingness to sign a written informed consent form (ICF).
9. Members of all races and ethnic groups are eligible for this trial.

1. Evidence of hormone-sensitive prostate cancer (HSPC)
2. Evidence of small cell prostate cancer
3. Subjects receiving any other investigational agents.
4. 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.
5. Subjects with brain metastases/central nervous system (CNS) disease that are treated prior to enrollment will be allowed in this clinical trial.
6. Known or suspected significant hypersensitivity to any components of the formulation used for Cabazitaxel, carboplatin or 177Lu-PSMA-617.
7. 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.
8. Prior treatment toxicities not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0

Contacts and Locations

Study Contact

Pedro Barata, MD, MSc

CONTACT

216-262-1214

Pedro.Barata@UHhospitals.org

Principal Investigator

Pedro Barata, MD, MSc

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

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

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

Pedro Barata, MD, MSc, PRINCIPAL_INVESTIGATOR, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-07

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Cabazitaxel
Lu-PSMA-617
Carboplatin

Additional Relevant MeSH Terms

Metastatic Prostate Cancer
Metastatic Castration-resistant Prostate Cancer