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NCT03456843 · ClinicalTrials.gov registry record · Phase 2
Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
A Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7, sponsored by Yale University.
- Active
- Registry status
- Phase 2
- Development phase
- 190
- Enrollment target
- 16
- Study locations
NCT03456843: Active Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7, sponsored by Yale University.
NCT03456843 is a Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 that is active but no longer recruiting, run by Yale University. The registered enrollment target is 190 participants, above the 139-participant average among 7 other Stage IV Prostate Adenocarcinoma AJCC v7 trials with a reported enrollment target (37% higher). The trial reports 16 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03456843, a Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 190 participants
- Enrollment target
- 16
- Study locations
Study Summary
This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.
Primary Outcome
Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test.
Conditions Studied
Interventions
- DRUG Docetaxel
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Antiandrogen Therapy
- PROCEDURE Quality-of-Life Assessment
Study Locations (16)
Other
- Chinese University of Hong Kong - Hong Kong
- Akita University - Akita
- Juntendo University - Tokyo
- National Cancer Center - Goyang-si
- Seoul National University Bundang Hospital - Gyeonggi-do
- Samsung Medical Center - Seoul
- National Taiwan University Hospital - Taipei
California
- City of Hope - Duarte
- University of California, Irvine - Irvine
- University of Southern California - Los Angeles
Connecticut
- Yale University - New Haven
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Pennsylvania
- University of Pennsylvania - Philadelphia
Washington
- Swedish Medical Services - Seattle
Australia
- Epworth Healthcare - East Melbourne
Osaka
- Kindai University - Ōsaka-sayama
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What the registry record for NCT03456843 still lists
NCT03456843 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 139-participant average among 7 other Stage IV Prostate Adenocarcinoma AJCC v7 trials with a reported enrollment target (37% higher).
The record links to 1 condition, with Stage IV Prostate Adenocarcinoma AJCC v7 appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT03456843 lists 16 locations in 8 states (Other, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT03456843 about?
NCT03456843 is a clinical study titled "Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer". This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandr...
What is the current status of trial NCT03456843?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2018-03-20. Estimated completion is 2027-03.
What conditions does trial NCT03456843 study?
This clinical trial studies the following conditions: Stage IV Prostate Adenocarcinoma AJCC v7.
What interventions are being tested in trial NCT03456843?
The interventions under investigation include: Docetaxel (DRUG), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Antiandrogen Therapy (DRUG), Quality-of-Life Assessment (PROCEDURE).
Who is sponsoring clinical trial NCT03456843?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03456843 being conducted?
This trial has 16 study locations across California, Connecticut, New Jersey, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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