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NCT04253483 · ClinicalTrials.gov registry record · Phase 2
Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer
A Phase 2 study of Stage II Prostate Cancer AJCC v8 and Stage I Prostate Cancer AJCC v8, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 3
- Study locations
NCT04253483 is a Phase 2 study of Stage II Prostate Cancer AJCC v8 and Stage I Prostate Cancer AJCC v8 that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 14 participants, below the 119-participant average among 21 other Stage II Prostate Cancer AJCC v8 trials with a reported enrollment target (88% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT04253483, a Phase 2 study of Stage II Prostate Cancer AJCC v8 and Stage I Prostate Cancer AJCC v8, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a few minutes by a single radioactive seed through temporarily placed plastic catheters inside the prostate gland. Stereotactic ablative radiotherapy is an external beam radiation method that delivers large doses of radiation to the cancer in a short period of time, usually 5 treatments. This trial aims to find which of these two approaches is better in terms of patient-reported quality of life.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION High-Dose Rate Brachytherapy
- PROCEDURE Stereotactic Ablative Radiotherapy
Study Locations (3)
New Jersey
- RWJBarnabas Health - Saint Barnabas Medical Center, Livingston - Livingston
- Rutgers Cancer Institute of New Jersey - New Brunswick
- Rutgers New Jersey Medical School - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-07-17 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04253483
The ClinicalTrials.gov registry entry for NCT04253483 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 21 other Stage II Prostate Cancer AJCC v8 trials with a reported enrollment target (88% lower). The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Stage II Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04253483 reports 3 study locations spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT04253483 about?
NCT04253483 is a clinical study titled "Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer". This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a fe...
What is the current status of trial NCT04253483?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2019-07-17. Estimated completion is 2027-09-01.
What conditions does trial NCT04253483 study?
This clinical trial studies the following conditions: Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT04253483?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), High-Dose Rate Brachytherapy (RADIATION), Stereotactic Ablative Radiotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT04253483?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04253483 being conducted?
This trial has 3 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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