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NCT03939689 · ClinicalTrials.gov registry record · Phase 2
I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).
A Phase 2 study of Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, sponsored by Progenics Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT03939689: Completed Phase 2 study of Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, sponsored by Progenics Pharmaceuticals.
NCT03939689 is a Phase 2 study of Metastatic Prostate Cancer and Castration-resistant Prostate Cancer that has completed, run by Progenics Pharmaceuticals. The registered enrollment target is 120 participants, below the 184-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03939689, a Phase 2 study of Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, has completed, sponsored by Progenics Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical trial was done to show whether a radioactive drug (I-131-1095) that binds to prostate-specific membrane antigen (PSMA) is useful in treating metastatic prostate cancer that is positive for PSMA. The trial enrolled men whose PSMA-positive metastatic prostate cancer had progressed while they were taking abiraterone. During the trial, all of the men took enzalutamide (standard-of-care therapy) once a day. However, some of the men also had up to 4 doses (8 weeks apart) of I-131-1095 (in addition to taking enzalutamide once a day). At specified times during the trial, all of the men had blood tests (to measure levels of prostate-specific antigen \[PSA\]) and imaging studies (to assess tumor status). The two groups of men were then compared in several ways. The main comparison was the percentage of men in each group with at least a 50% decrease in PSA levels. Other comparisons involved the response of the tumors (as seen on imaging) and overall survival. To assess safety, the number of adverse events in both groups were also compared.
Primary Outcome
The percentage of participants with a PSA response according to PCWG3 criteria. PCWG3 defines PSA response as the first occurrence of a 50 percent or more decline in PSA from baseline, confirmed by a second measurement at least 3 weeks later.
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG I-131-1095
Study Locations (20)
California
- City of Hope - Duarte
- VA Greater Los Angeles Healthcare System - Los Angeles
- UCLA - Los Angeles
- Hoag Family Cancer Institute - Newport Beach
- VA Palo Alto Healthcare System - Palo Alto
Washington
- Virginia Mason Medical Center - Seattle
- University of Washington - Seattle Cancer Care Alliance - Seattle
District of Columbia
- Medstar Georgetown University Hospital - Washington D.C.
Illinois
- The University of Chicago - Chicago
Iowa
- University of Iowa - Iowa City
Louisiana
- Tulane Medical School - New Orleans
Maryland
- University of Maryland - Baltimore
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-05-30 |
| Est. Completion | 2024-09-24 |
| Phase | Phase 2 |
What the finished NCT03939689 record still lists
NCT03939689 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 184-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (35% lower).
The record links to 5 conditions, with Metastatic Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Enzalutamide is the first listed.
NCT03939689 names 20 study sites across 15 states, led by California, Washington, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03939689 about?
NCT03939689 is a clinical study titled "I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).". This clinical trial was done to show whether a radioactive drug (I-131-1095) that binds to prostate-specific membrane antigen (PSMA) is useful in treating metastatic prostate cancer that is positive for PSMA. The trial enrolled men whose PSMA-positive metastatic prostate cancer had progressed while ...
What is the current status of trial NCT03939689?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2019-05-30. Estimated completion is 2024-09-24.
What conditions does trial NCT03939689 study?
This clinical trial studies the following conditions: Metastatic Prostate Cancer, Castration-resistant Prostate Cancer, Cancer of the Prostate, Prostatic Neoplasm, Progressive mCRPC.
What interventions are being tested in trial NCT03939689?
The interventions under investigation include: Enzalutamide (DRUG), I-131-1095 (DRUG).
Who is sponsoring clinical trial NCT03939689?
This trial is sponsored by Progenics Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03939689 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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