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NCT01250717 · ClinicalTrials.gov registry record · Phase 2
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT01250717: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT01250717 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01250717, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.
Primary Outcome
One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each pr
Interventions
- DRUG Docetaxel
- DRUG Dexamethasone
- DRUG Zoladex
- DRUG Estramustine
- DRUG Casodex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2001-01 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT01250717 record still lists
NCT01250717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT01250717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01250717 about?
NCT01250717 is a clinical study titled "Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer". The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may...
What is the current status of trial NCT01250717?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2001-01. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01250717?
The interventions under investigation include: Docetaxel (DRUG), Dexamethasone (DRUG), Zoladex (DRUG), Estramustine (DRUG), Casodex (DRUG).
Who is sponsoring clinical trial NCT01250717?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01250717's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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