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Antiandrogen Withdrawal in Treating Patients With Hormone-Refractory Prostate Cancer

NCT00002760 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2016-06-28

No results posted yet for this study

Summary

RATIONALE: Antiandrogen withdrawal may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of ketoconazole and hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is refractory to hormone therapy.

Conditions

Interventions

DRUG

ketoconazole

400 mg PO tid for as long as treatment is effective

DRUG

therapeutic hydrocortisone

hydrocortisone 30 mg PO q am and 10 mg PO qhs for as long as treatment is effective

OTHER

Withdrawal of antiandrogen therapy

no drugs given

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Eric Small, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-08-31
Primary Completion
2004-03-31
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00002760 on ClinicalTrials.gov