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NCT00425503 · ClinicalTrials.gov registry record · Phase 2
PS-341 Followed by Removal of Prostate for Those With Prostate Cancer
A Phase 2 study of Prostate Neoplasms, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00425503: Completed Phase 2 study of Prostate Neoplasms, sponsored by Baylor College of Medicine.
NCT00425503 is a Phase 2 study of Prostate Neoplasms that has completed, run by Baylor College of Medicine. The registered enrollment target is 40 participants, below the 141-participant average among 4 other Prostate Neoplasms trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00425503, a Phase 2 study of Prostate Neoplasms, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Following pretreatment evaluation, patients receive PS-341 by intravenous push weekly for 4 consecutive weeks followed by a 24-72 hour rest period. This schedule consists of one treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest period, radical prostatectomy will be performed. Surgery will be delayed if there is any bleeding abnormality (bleeding time greater than 10 minutes) and until platelet count is more than or equal to 100,000 and coagulation profile (PT, PTT) is normal. If at the time of surgery a patient is found to have positive lymph nodes, prostatectomy will be abandoned, the prostate will be biopsied, and the patient will be offered other treatment modalities (hormones, radiation therapy).
Primary Outcome
Pour wound healing is defined in the protocol as dehiscence of fascia during the first postoperative week. Excessive bleeding is defined in the protocol as greater than 2 units of blood required during the first 24 hours after surgery.
Conditions Studied
Interventions
- DRUG PS-341 (bortezomib)
Study Locations (1)
Texas
- Scott Department of Urology, Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2001-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT00425503 record still lists
NCT00425503 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 141-participant average among 4 other Prostate Neoplasms trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Prostate Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which PS-341 (bortezomib) is the first listed.
NCT00425503 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00425503 about?
NCT00425503 is a clinical study titled "PS-341 Followed by Removal of Prostate for Those With Prostate Cancer". Following pretreatment evaluation, patients receive PS-341 by intravenous push weekly for 4 consecutive weeks followed by a 24-72 hour rest period. This schedule consists of one treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest period, radical prostatectomy will...
What is the current status of trial NCT00425503?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2001-12. Estimated completion is 2013-12.
What conditions does trial NCT00425503 study?
This clinical trial studies the following conditions: Prostate Neoplasms.
What interventions are being tested in trial NCT00425503?
The interventions under investigation include: PS-341 (bortezomib) (DRUG).
Who is sponsoring clinical trial NCT00425503?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00425503 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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