Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer
Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 19 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares cabazitaxel, with or without carboplatin, to 177Lu-PSMA-617 to see which treatment works best. It is for adults with prostate cancer that has spread, no longer responds to hormone treatment, and shows a protein called PSMA on a scan. Prior treatment with docetaxel is recommended but not required.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be older than 18 and have prostate adenocarcinoma, a type of prostate cancer, confirmed by a lab report.
- Have cancer that has spread and gotten worse after treatment with a newer hormone-blocking drug.
- Have a recent PSMA PET scan that meets the study’s rules for timing and PSMA levels.
- Have at least one of these: a low average PSMA scan level, cancer in an internal organ, cancer in at least 5 bone sites, or a TP53 or PTEN gene change shown on testing within 5 years.
- Be able to do self-care and be out of bed or a chair for at least half of waking hours. Blood counts and organ tests must meet study limits, with no blood cell growth drugs in the past 7 days or blood transfusions in the past 14 days before screening blood tests.
- If taking medicine to protect bones, be on a steady dose for at least 14 days before study treatment.
- If able to father a child, agree to use highly effective birth control and not donate sperm during treatment and for 3 months after the last dose. Partners must also use approved birth control.
- Be able to understand the study and agree to sign a consent form. People of all races and ethnic groups may join.
Who can't join
- Prostate cancer that still responds to hormone treatment, or small cell prostate cancer.
- Taking another experimental drug.
- Another significant cancer diagnosed in the past 2 years. Some cancers treated to cure them, or cancers that have not spread into nearby tissue, may be allowed.
- Brain or central nervous system disease that has not been treated before joining. Previously treated disease is allowed.
- A known or suspected serious allergy to ingredients in cabazitaxel, carboplatin, or 177Lu-PSMA-617.
- An uncontrolled illness, such as an active infection or serious heart problem, or a mental health or social issue that could prevent following study rules.
- Side effects from earlier treatment that are still worse than moderate.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
OH
- Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center · Cleveland, OH 44106Pedro Barata, MD, MSc · Study contactMore trials in Cleveland