Suspended

Adjuvant Hormonal Therapy for High-Risk Post-Prostatectomy Patients

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What is being tested

Flutamide

+ Leuprolide Acetate

Drug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 1999
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: April 28, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: June 14, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression. Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival. Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels. Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition. Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. Arm II: Patients receive no initial treatment. Quality of life is assessed every 6 months for 5 years. Quality of life of wives/partners of patients is assessed every 6 months for two years. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years.

NCT00003645
Principal SponsorM.D. Anderson Cancer Center
Last updated: April 28, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

6 inclusion criteria required to participate
High risk of clinical or biochemical failure post prostatectomy (must fulfill one of the following criteria): pathology; a) Gleason grade sum score greater than or equal to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive surgical margins and Gleason greater than or equal to 7
Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging
Pathologic assessment of surgical specimens by MDACC pathologist
Radical prostatectomy and bilateral lymph node dissection performed
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8 exclusion criteria prevent from participating
Active secondary malignancy (other than squamous or basal cell skin cancer) within five years prior to enrollment in study
Any concomitant medical condition that would make it undesirable for the 7patient to participate in the trial or jeopardize compliance with the protocol
Any evidence of metastatic disease confirmed prior to enrollment
Contraindication to the use of LH-RH agonists or antiandrogens
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.

Group II

No Intervention
Arm II: Patients receive no initial treatment.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Texas - MD Anderson Cancer Center

Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps
SuspendedOne Study Center