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NCT01076335 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01076335: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01076335 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01076335, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.
Primary Outcome
Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml - 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant re
Interventions
- DRUG Docetaxel
- DRUG Neoadjuvant Hormonal Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01076335 record still lists
NCT01076335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT01076335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01076335 about?
NCT01076335 is a clinical study titled "Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer". The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.
What is the current status of trial NCT01076335?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2005-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01076335?
The interventions under investigation include: Docetaxel (DRUG), Neoadjuvant Hormonal Therapy (DRUG).
Who is sponsoring clinical trial NCT01076335?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01076335's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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