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NCT03541850 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
A Phase 2 study of PSA Progression and Stage III Prostate Adenocarcinoma AJCC v7, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 2
- Study locations
NCT03541850: Active Phase 2 study of PSA Progression and Stage III Prostate Adenocarcinoma AJCC v7, sponsored by Jonsson Comprehensive Cancer Center.
NCT03541850 is a Phase 2 study of PSA Progression and Stage III Prostate Adenocarcinoma AJCC v7 that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 92 participants, below the 268-participant average among 5 other PSA Progression trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03541850, a Phase 2 study of PSA Progression and Stage III Prostate Adenocarcinoma AJCC v7, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.
Primary Outcome
Defined as serum prostate-specific antigen (PSA) rising from the post-treatment nadir to a level of 0.4 ng/mL or more with a confirmatory second test, initiation of salvage androgen deprivation therapy, or continued rise in PSA after stereotactic body radiation therapy (SBRT). The Kaplan-Meier product-limit estimate of the BCRFS will be estimated and presented graphically. One sample log-rank test will be used to test difference in BCRFS between intervention and historical control. The median BC
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- RADIATION Stereotactic Body Radiation Therapy
- DRUG Antiandrogen Therapy
Study Locations (2)
California
- USC Norris Comprehensive Cancer Center and Hospital - Los Angeles
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 2 |
What the registry record for NCT03541850 still lists
NCT03541850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 268-participant average among 5 other PSA Progression trials with a reported enrollment target (66% lower).
The record links to 5 conditions, with PSA Progression appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03541850 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03541850 about?
NCT03541850 is a clinical study titled "Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery". This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the...
What is the current status of trial NCT03541850?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2019-01-29. Estimated completion is 2027-11-01.
What conditions does trial NCT03541850 study?
This clinical trial studies the following conditions: PSA Progression, Stage III Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7, PSA Level Greater Than 0.03, Stage I Prostate Adenocarcinoma AJCC (American Joint Committee on Cancer ) v7.
What interventions are being tested in trial NCT03541850?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Stereotactic Body Radiation Therapy (RADIATION), Antiandrogen Therapy (DRUG).
Who is sponsoring clinical trial NCT03541850?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03541850 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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