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Radioligand Therapy
Phase 1B: Dose Expansion for Prostate Cancer
Phase 1
Waitlist Available
Led By Praful Ravi, MB BCHir, MRCP
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial aims to determine if a combination of chemotherapy drug, carboplatin, and radioligand treatment, 177Lu-PSMA-617, is safe and effective in treating prostate cancer
Who is the study for?
This trial is for men with metastatic castrate-resistant prostate cancer. Participants should not have had previous chemotherapy for their condition and must be able to perform daily activities without significant assistance.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of combining a chemotherapy drug, Carboplatin, with a radioligand therapy called 177Lu-PSMA-617 in treating advanced prostate cancer.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, kidney issues from the radioligand therapy, and allergic reactions to the chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) or the Recommended Phase 2 dose (RP2D) of carboplatin administered in combination with 177Lu-PSMA-617
Secondary outcome measures
Overall Response Rate (ORR)
Overall Survival (OS)
PSA response rate (PSA reduction by ≥50% from baseline).
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1B: Dose ExpansionExperimental Treatment2 Interventions
19 additional participants will be enrolled at the RP2D of carboplatin and will complete:
Baseline visit.
Day 1 of Cycles 3 and 5: Tumor assessment radiologic scans.
Tumor biopsy at baseline and at 12 weeks.
Cycle 1 through End of Treatment:
Days 1 and 22 of 42 day cycle: Predetermined dose of carboplatin every 3 weeks for a maximum of up to 6 cycles.
Day 2 of 42 day cycle: Predetermined dose of 177Lu-PSMA-617 every 6 weeks for a maximum of up to 6 cycles.
End of treatment visit.
Follow up visits in-office or via telephone.
Group II: Phase 1A: Dose EscalationExperimental Treatment2 Interventions
Participants will be enrolled in a 3+3 dose escalation design to establish a maximum tolerated dose (MTD) of carboplatin, starting at Dose Level 1 and escalating to Dose Level 2 or 3.
Baseline visit.
Day 1 of Cycles 3 and 5: Tumor assessment radiologic scans.
Cycle 1 through End of Treatment:
Days 1 and 22 of 42-day cycle: Predetermined dose of carboplatin every 3 weeks for a maximum of up to 6 cycles.
Day 2 of 42-day cycle: Predetermined dose of 177Lu-PSMA-617 every 6 weeks for a maximum of up to 6 cycles.
End of treatment visit.
Follow up visits in-office or via telephone. If 0 out of 3 participants experience a dose-limiting toxicity (DLT), the study will proceed to the next dose level. If 1 or more participants experience a DLT, this dose level is declared the MTD and study will not proceed to expansion. If 1 out of 6 participants at the highest dose level experience DLTs, this is the recommended Phase 1B dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
177Lu-PSMA-617
2018
Completed Phase 3
~840
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,911 Total Patients Enrolled
76 Trials studying Prostate Cancer
16,068 Patients Enrolled for Prostate Cancer
NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,233 Total Patients Enrolled
21 Trials studying Prostate Cancer
4,897 Patients Enrolled for Prostate Cancer
Praful Ravi, MB BCHir, MRCPPrincipal InvestigatorDana-Farber Cancer Institute
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions for patients to participate in this clinical trial?
"According to information on clinicaltrials.gov, the present trial is not in the recruitment phase. Its initial posting was recorded on April 1st, 2024 and its most recent modification occurred on March 8th, 2024. Despite this specific study being inactive for recruitment currently, there are approximately 1377 alternative trials actively seeking participants at this time."
Answered by AI
Is Phase 1A: Dose Escalation deemed safe for individuals undergoing treatment?
"Given the preliminary nature of Phase 1A: Dose Escalation, our team at Power rates its safety as a mere 1 on the scale due to minimal available data supporting both safety and efficacy."
Answered by AI
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