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Radiopharmaceutical

177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization assessed up to 4 years (estimated final os analysis)
Awards & highlights
No Placebo-Only Group

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization assessed up to 4 years (estimated final os analysis)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization assessed up to 4 years (estimated final os analysis) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I: Incidence of dose limiting toxicities (DLTs) during first cycle of study treatment.
Phase II: Prostate-Specific Antigen (PSA) response rate 50
Secondary study objectives
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)
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
36 Previous Clinical Trials
2,949 Total Patients Enrolled
4 Trials studying Prostate Cancer
230 Patients Enrolled for Prostate Cancer
Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals
2,224 Previous Clinical Trials
4,115,063 Total Patients Enrolled
19 Trials studying Prostate Cancer
3,635 Patients Enrolled for Prostate Cancer
~4 spots leftby Dec 2025
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