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Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer

NCT00223665 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-08-07

Study results available
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Summary

This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation. Patients received Intermittent Androgen Suppression (IAS) in 9 month cycles until they became metastatic, became castrate resistant, or withdrew from the study. Subjects were monitored for time to development of Castration Resistant Prostate Cancer (CRPC) and overall survival. They were also monitored for the impact of IAS on a variety of neuro-psychiatric assessments and on bone density.

Conditions

Interventions

DRUG

Flutamide

Flutamide dosed at 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate.

DRUG

Leuprolide Acetate

Leuprolide Acetate dosed at 7.5mg intramuscular (IM) injections once per month for a total of 9 months.

Sponsors & Collaborators

Principal Investigators

  • Celestia Higano, MD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-01-08
Primary Completion
2012-09-06
Completion
2012-09-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00223665 on ClinicalTrials.gov