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Radiopharmaceutical
177Lu-PSMA-R2 for Prostate Cancer (PROter Trial)
Phase 1
Waitlist Available
Research Sponsored by Advanced Accelerator Applications
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male patients, 18 years of age or older
Must have received prior systemic treatment for mCRPC including CYP17 inhibitors and/or androgen-pathway inhibitors (i.e. abiraterone and/or enzalutamide when available) and one and no more than one line of chemotherapy for the advanced disease (unless ineligible (unfit) to receive chemotherapy).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization assessed up to 4 years (estimated final os analysis)
Awards & highlights
PROter Trial Summary
This trial is testing a new treatment for prostate cancer that has spread and is resistant to hormone therapy. They are testing to see if it is safe and effective.
Eligible Conditions
- Prostate Cancer
PROter Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROter Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization assessed up to 4 years (estimated final os analysis)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization assessed up to 4 years (estimated final os analysis)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Incidence of dose limiting toxicities (DLTs) during first cycle of study treatment.
Phase II: Prostate-Specific Antigen (PSA) response rate 50
Secondary outcome measures
Phase I and II: Brief Pain Inventory-short Form (PBI-SF)
Phase I and II: Duration of Response (DoR)
Phase I and II: Objective Response Rate (ORR)
+16 morePROter Trial Design
6Treatment groups
Experimental Treatment
Group I: Phase I: Dose Escalation Cohort 6Experimental Treatment1 Intervention
18.5 GBq (500 mCi) up to 3 times
Group II: Phase I: Dose Escalation Cohort 5Experimental Treatment1 Intervention
18.5 GBq (500 mCi) up to 4 times
Group III: Phase I: Dose Escalation Cohort 4Experimental Treatment1 Intervention
14.8 GBq (400 mCi) up to 4 times
Group IV: Phase I: Dose Escalation Cohort 3Experimental Treatment1 Intervention
11.1 GBq (300 mCi) up to 4 times
Group V: Phase I: Dose Escalation Cohort 2Experimental Treatment1 Intervention
7.40 GBq (200 mCi) up to 4 times
Group VI: Phase I: Dose Escalation Cohort 1Experimental Treatment1 Intervention
3.70 GBq (100 mCi) x 3 times
Find a Location
Who is running the clinical trial?
Advanced Accelerator ApplicationsLead Sponsor
35 Previous Clinical Trials
2,920 Total Patients Enrolled
4 Trials studying Prostate Cancer
230 Patients Enrolled for Prostate Cancer
Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals
2,151 Previous Clinical Trials
4,011,669 Total Patients Enrolled
19 Trials studying Prostate Cancer
3,603 Patients Enrolled for Prostate Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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