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Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c

NCT00817739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2015-07-29

No results posted yet for this study

Summary

This study is aimed at evaluating the effects of intermittent hormonal treatment with complete androgen suppression (Leuprorelin 3.75 milligram \[mg\] sustained release \[SR\] and Flutamide) in patients presenting with stage D2 or Tx Nx M1 ≠ M1a metastatic prostrate cancer, with a prostate specific antigen (PSA) level 5-fold higher than normal (PSA greater than or equal to \[≥\] 20 nanogram per milliliter \[ng/mL\], as quantitated by the Hybritech radioimmunoassay) and with a subsequent decline to normal (PSA less than \[\<\] 4 ng/mL) during the initial 6 months of induction treatment. The results will be compared with those obtained after continuous hormonal therapy with complete androgen suppression.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Leuprorelin

Leuprorelin injection

DRUG

Flutamide

Flutamide tablets

Sponsors & Collaborators

Principal Investigators

  • Nicolas MOTTET, MD · Clinique Mutualiste de Saint-Etienne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-12-31
Primary Completion
2005-09-30
Completion
2008-12-31

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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 NCT00817739 on ClinicalTrials.gov