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PS-341 Followed by Removal of Prostate for Those With Prostate Cancer

NCT00425503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-04-21

Study results available
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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

  • Prostate Neoplasms

Interventions

DRUG

PS-341 (bortezomib)

PS-341 is a dipeptidyl boronic acid inhibitor with high specificity for the proteasome developed by Millennium Pharmaceuticals Inc. to treat human malignancies. It is the first member of this class of anti-tumor agents to come to human trials. Patients will receive PS-341 (1.6mg/m2/dose) by intravenous push weekly for 4 consecutive weeks followed by a 24-72 hour rest. 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.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Teresa Hayes, M.D., Ph.D. · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2012-11-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00425503 on ClinicalTrials.gov