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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 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.

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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).

Conditions Studied

Interventions

  • DRUG PS-341 (bortezomib)

Study Locations (1)

Texas

  • Scott Department of Urology, Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2001-12
Est. Completion 2013-12
Phase Phase 2

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT00425503

The ClinicalTrials.gov registry entry for NCT00425503 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 141-participant average among 4 other Prostate Neoplasms trials with a reported enrollment target (72% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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