I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).
Public ClinicalTrials.gov record NCT03939689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Controlled Phase 2 Study: Efficacy and Safety of I-131-1095 Radiotherapy in Combination With Enzalutamide in mCRPC Patients Who Are 18F-DCFPyL PSMA-avid, Chemotherapy-naïve, and Progressed on Abiraterone (ARROW )
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03939689
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 30, 2019 (Actual)
- Primary completion
- Sep 21, 2023 (Actual)
- Completion
- Sep 24, 2024 (Actual)
- Last update posted
- Oct 14, 2025
2019 – 2024
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | — |
| UCLA | Los Angeles | California | 90095-7370 | — |
| Hoag Family Cancer Institute | Newport Beach | California | 92663 | — |
| VA Palo Alto Healthcare System | Palo Alto | California | 94303 | — |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| The University of Chicago | Chicago | Illinois | 60637 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Tulane Medical School | New Orleans | Louisiana | 70112 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| LifeSpan Cancer Institute | Providence | Rhode Island | 09206 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03939689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03939689 live on ClinicalTrials.gov.