Metastatic Prostate CancerPhase 2CATCH-177NCT06738303
Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer
A Phase 2 study testing Cabazitaxel and carboplatin and Lu-PSMA-617 in people with Metastatic Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Cabazitaxel and carboplatin and Lu-PSMA-617
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 1 Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44106
Pedro Barata, MD, MSc
About this study
Official title: Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)
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.
Read the detailed description
Brief Background/Rationale
Metastatic prostate cancer initially is very responsive to androgen deprivation therapy (ADT), with intensification using an androgen receptor pathway inhibitor (ARPI) such as abiraterone acetate, enzalutamide, apalutamide, or darolutamide with or without docetaxel to prolong sensitivity to treatment and overall survival. Over time, however, prostate cancer transitions from castrate-sensitive to castrate-resistant. Metastatic castrate-resistant prostate cancer (mCRPC) has a dismal prognosis, with a median survival of under three years. There are now several agents with diverse mechanisms of action approved for use in mCRPC including cabazitaxel, sipuleucel-T, abiraterone acetate, enzalutamide, radium-223, olaparib, rucaparib, and 177Lu-PSMA-617.
Despite the treatment advances in the past decade, many cases of mCRPC either do not respond to these treatments or only respond for a short period of time. Predictive biomarkers are needed. In addition, with several options available, it is not always clear the optimal sequencing of these agents.
- Being tested
- Cabazitaxel and carboplatin, Lu-PSMA-617
- Keywords
- Cabazitaxel, Lu-PSMA-617, Carboplatin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabazitaxel and carboplatinDrug
Given IV
Lu-PSMA-617Drug
Also called Pluvicto
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Lu-PSMA-617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks post intervention
Secondary outcomes (2)
Progression Free Survival
Measured: Upto 26 weeks
Time to next systemic therapy
Measured: Cycle 1 day1(each cycle will be 6 weeks upto 10 cycles) to the first day of subsequent systemic cancer-directed therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start14 Jul 2025
- Primary completion20 Feb 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Barata, MD, MSc, Principal investigator, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738303
- Sponsor's protocol ID
- CASE13824
- Acronym
- CATCH-177
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes