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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: Completed Phase 1 study of Metastatic Prostate Carcinoma and Metastatic Prostatic Adenocarcinoma, sponsored by Rutgers, The State University of New Jersey.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Rate will be calculated for the primary end point, and one-sided Binomial test will be used to compare the rate to the hypothesized value. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.
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 |
What the finished NCT02458716 record still lists
NCT02458716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 132-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02458716's enrollment target sits among peer trials
26 29th of 37 higher than 9 of 37 other Metastatic Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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