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COMPLETED Phase 2

Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy

NCT02203695 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 86 participants
Start Date 2015-03-28
Est. Completion 2022-12-31
Phase Phase 2

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02203695 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Maryland, Michigan, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02203695?

The interventions under investigation include: Enzalutamide (DRUG), SRT (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02203695?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial