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NCT02203695 · ClinicalTrials.gov registry record · Phase 2
Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy
A Phase 2 study of Adenocarcinoma of the Prostate, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 9
- Study locations
NCT02203695 is a Phase 2 study of Adenocarcinoma of the Prostate that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 86 participants, below the 105-participant average among 21 other Adenocarcinoma of the Prostate trials with a reported enrollment target (18% lower). The trial reports 9 study locations across 7 states.
The verdict
NCT02203695, a Phase 2 study of Adenocarcinoma of the Prostate, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 9
- Study locations
Study Summary
The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the definitive phase III setting. This study builds on the prior success of high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6 months) in an effort to minimize adverse effects.
Conditions Studied
Interventions
- DRUG Enzalutamide
- RADIATION SRT
Study Locations (9)
Maryland
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
- Suburban Hospital - Bethesda
Michigan
- University of Michigan Health System - Ann Arbor
- Karmanos Cancer Center - Detroit
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Illinois
- University of Chicago Medical Center - Chicago
Indiana
- Indiana University - Lafayette
Oregon
- Oregon Health Sciences University - Portland
Utah
- University of Utah - Huntsman Cancer Center - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2015-03-28 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02203695
The ClinicalTrials.gov registry entry for NCT02203695 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 105-participant average among 21 other Adenocarcinoma of the Prostate trials with a reported enrollment target (18% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adenocarcinoma of the Prostate appearing as the primary indexed condition, and to 2 interventions - of which Enzalutamide is the first listed.
NCT02203695 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Maryland, Michigan, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02203695 about?
NCT02203695 is a clinical study titled "Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy". The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the defin...
What is the current status of trial NCT02203695?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2015-03-28. Estimated completion is 2022-12-31.
What conditions does trial NCT02203695 study?
This clinical trial studies the following conditions: Adenocarcinoma of the Prostate.
What interventions are being tested in trial NCT02203695?
The interventions under investigation include: Enzalutamide (DRUG), SRT (RADIATION).
Who is sponsoring clinical trial NCT02203695?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02203695 being conducted?
This trial has 9 study locations across District of Columbia, Illinois, Indiana, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.