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I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).
NCT03939689 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03939689
The ClinicalTrials.gov registry entry for NCT03939689 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Progenics Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03939689 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Washington, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Cancer of the Prostate, Castration-resistant Prostate Cancer, Prostatic Neoplasm, Progressive mCRPC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03939689?
The interventions under investigation include: Enzalutamide (DRUG), I-131-1095 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03939689?
This trial is sponsored by Progenics Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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