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NCT02949284 · ClinicalTrials.gov registry record · Phase 2
Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
A Phase 2 study of Stage II Prostate Adenocarcinoma and Stage III Prostate Adenocarcinoma, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT02949284: Active Phase 2 study of Stage II Prostate Adenocarcinoma and Stage III Prostate Adenocarcinoma, sponsored by Rutgers, The State University of New Jersey.
NCT02949284 is a Phase 2 study of Stage II Prostate Adenocarcinoma and Stage III Prostate Adenocarcinoma that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02949284, a Phase 2 study of Stage II Prostate Adenocarcinoma and Stage III Prostate Adenocarcinoma, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study Summary
This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in treating patients with prostate cancer.
Primary Outcome
Each of the experimental arms will be compared to the surgery-only arm, so each test will be a 2.5% level one-sided test to control for the fact that there are two comparisons.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Prednisone
- DRUG Abiraterone Acetate
- BIOLOGICAL Gonadotropin-releasing Hormone Analog
- DRUG Androgen Receptor Antagonist ARN-509
Study Locations (2)
Connecticut
- Yale Cancer Center - New Haven
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-06-20 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What the registry record for NCT02949284 still lists
NCT02949284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 2 conditions, with Stage II Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02949284 reports a single indexed study location in Connecticut, New Jersey.
Frequently Asked Questions
What is clinical trial NCT02949284 about?
NCT02949284 is a clinical study titled "Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery". This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause the growth of prostate can...
What is the current status of trial NCT02949284?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2017-06-20. Estimated completion is 2027-06.
What conditions does trial NCT02949284 study?
This clinical trial studies the following conditions: Stage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma.
What interventions are being tested in trial NCT02949284?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Prednisone (DRUG), Abiraterone Acetate (DRUG), Gonadotropin-releasing Hormone Analog (BIOLOGICAL), Androgen Receptor Antagonist ARN-509 (DRUG).
Who is sponsoring clinical trial NCT02949284?
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 NCT02949284 being conducted?
This trial has 2 study locations across Connecticut, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02949284's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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