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NCT02458716 · ClinicalTrials.gov registry record · Phase 1
Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer
A Phase 1 study of Metastatic Prostate Carcinoma and Metastatic Prostatic Adenocarcinoma, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT02458716 is a Phase 1 study of Metastatic Prostate Carcinoma and Metastatic Prostatic Adenocarcinoma that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 26 participants, below the 132-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT02458716, a Phase 1 study of Metastatic Prostate Carcinoma and Metastatic Prostatic Adenocarcinoma, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Robotic Assisted Radical Prostatectomy
- PROCEDURE Conventional open retropubic radical prostectomy
- DRUG ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
Study Locations (3)
California
- City of Hope National Medical Center (COH) - Duarte
- University of California, Irvine (UCI) - Orange
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-03-06 |
| Est. Completion | 2020-01-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02458716
The ClinicalTrials.gov registry entry for NCT02458716 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 132-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (80% 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 3 conditions, with Metastatic Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02458716 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, New Jersey.
Frequently Asked Questions
What is clinical trial NCT02458716 about?
NCT02458716 is a clinical study titled "Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer". This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor ...
What is the current status of trial NCT02458716?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2015-03-06. Estimated completion is 2020-01-14.
What conditions does trial NCT02458716 study?
This clinical trial studies the following conditions: Metastatic Prostate Carcinoma, Metastatic Prostatic Adenocarcinoma, Prostate Carcinoma Metastatic to the Bone.
What interventions are being tested in trial NCT02458716?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Robotic Assisted Radical Prostatectomy (PROCEDURE), Conventional open retropubic radical prostectomy (PROCEDURE), ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide) (DRUG).
Who is sponsoring clinical trial NCT02458716?
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 NCT02458716 being conducted?
This trial has 3 study locations across California, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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