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Anti-tumor antibiotic
Cabazitaxel/Carboplatin vs Lu-PSMA-617 for Prostate Cancer (CATCH-177 Trial)
Cleveland, OH
Phase 2
Waitlist Available
Led By Pedro Barata, MD, MSc
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years.
ECOG performance status of 0 to 2.
Must not have
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.
Evidence of hormone-sensitive prostate cancer (HSPC).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks post intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine the most effective treatment for patients with advanced prostate cancer who have not responded to hormone therapy and docetaxel, and who are also positive for Prostate-specific membrane antigen (
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Who is the study for?
This trial is for men with advanced prostate cancer that has spread and isn't responding to hormone therapy or docetaxel. Participants must have tumors that are PSMA positive, indicating a specific protein is present on their cancer cells.Check my eligibility
What is being tested?
The study compares two treatments: one group receives Cabazitaxel with Carboplatin, while the other gets an experimental treatment called Lu-PSMA-617. The goal is to determine which treatment works best for this type of cancer.See study design
What are the potential side effects?
Cabazitaxel and Carboplatin can cause nausea, hair loss, nerve damage, low blood cell counts increasing infection risk. Lu-PSMA-617 may lead to dry mouth, kidney issues, and temporary bone marrow suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I can care for myself and am up and about more than half of my waking hours.
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My blood counts and liver/kidney functions are within the required ranges for treatment.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious illnesses that are not under control.
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My prostate cancer responds to hormone therapy.
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My prostate cancer is of the small cell type.
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My side effects from previous treatments are mild or gone.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks post intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PSA response rate as assessed by the change in PSA ratio
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Lu-PSMA-617Experimental Treatment1 Intervention
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
Group II: Arm 1: Cabazitaxel and carboplatinExperimental Treatment1 Intervention
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
Find a Location
Closest Location:Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center· Cleveland, OH· 127 miles
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
471 Previous Clinical Trials
33,361 Total Patients Enrolled
29 Trials studying Prostate Cancer
2,986 Patients Enrolled for Prostate Cancer
Pedro Barata, MD, MScPrincipal InvestigatorCase Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center, Cleveland Clinic Taussig Cancer Institute
1 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Prostate Cancer
13 Patients Enrolled for Prostate Cancer