Hormone Therapy in Treating Patients Who Have Stage I or Stage II Prostate Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborators:	National Cancer Institute (NCI) Eastern Cooperative Oncology Group
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00003645

Purpose

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.

Condition	Intervention	Phase
Prostate Cancer	Drug: Flutamide Drug: Leuprolide Acetate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Randomized Prospective Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Flutamide Leuprolide Goserelin Leuprolide acetate Bicalutamide

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Patients with Disease-free Survival at 5 Years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	496
Study Start Date:	June 1999
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I - Leuprolide + Flutamide Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.	Drug: Flutamide 10.8 mg intramuscularly once every 3 months for 12 months Other Names: Goserelin Zoladex Drug: Leuprolide Acetate 50 mg tablet orally daily for 12 months Other Names: Casodex Bicalutamide
No Intervention: Arm II - No Treatment Arm II: Patients receive no initial treatment.

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging
Radical prostatectomy and bilateral lymph node dissection performed
Pathologic assessment of surgical specimens by MDACC pathologist
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
Radical prostatectomy performed within 90 days of enrollment and serum PSA level < 0.1ng/ml
Written informed consent

Exclusion Criteria:

Any evidence of metastatic disease confirmed prior to enrollment
Inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5).
Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer
Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study
Elevation of liver function tests 2x normal
Contraindication to the use of LH-RH agonists or antiandrogens
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003645

Locations

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Investigators

Study Chair:	Curtis A. Pettaway, MD	M.D. Anderson Cancer Center
Study Chair:	Michael O. Koch, MD	Indiana University Melvin and Bren Simon Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Curtis A. Pettaway, M.D., UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00003645 History of Changes
Other Study ID Numbers:	ID97-077, P30CA016672, MDA-ID-97077, E-97077, NCI-T97-0069, CDR0000066733
Study First Received:	November 1, 1999
Last Updated:	May 31, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Flutamide
Leuprolide
Bicalutamide
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 13, 2012