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NCT03503344 · ClinicalTrials.gov registry record · Phase 2
Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT03503344: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT03503344 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03503344, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
This phase II trial studies the how well apalutamide with or without stereotactic body radiation therapy work in treating participants with castration-resistant prostate cancer. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. It is not yet known whether giving apalutamide with or without stereotactic body radiation therapy works better in treating participants with castration-resistant cancer.
Primary Outcome
The primary endpoint for the study is the proportion of participants with undetectable serum PSA (\< 0.2 ng/mL) at 6 months following completion of apalutamide therapy (18 months from date of randomization). Participants who discontinue apalutamide prior to completion of 12 months of therapy for reasons other than disease progression by Prostate Cancer Clinical Trials Working Group (PCWG) criteria, as well as participants who withdraw or are lost to follow up, will be considered unevaluable for
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- DRUG Apalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2025-10-31 |
| Phase | Phase 2 |
What the finished NCT03503344 record still lists
NCT03503344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT03503344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03503344 about?
NCT03503344 is a clinical study titled "Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer". This phase II trial studies the how well apalutamide with or without stereotactic body radiation therapy work in treating participants with castration-resistant prostate cancer. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by...
What is the current status of trial NCT03503344?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-12-17. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT03503344?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Apalutamide (DRUG).
Who is sponsoring clinical trial NCT03503344?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03503344's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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