Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hormone Therapy in Treating Patients Who Have Stage I or Stage II Prostate Cancer

This study is ongoing, but not recruiting participants.
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: November 1, 1999
Last updated: June 16, 2014
Last verified: June 2014

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 3

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:

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 2016
Estimated Primary Completion Date: June 2016 (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:


  • 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.


Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging
  2. Radical prostatectomy and bilateral lymph node dissection performed
  3. Pathologic assessment of surgical specimens by MDACC pathologist
  4. 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
  5. Radical prostatectomy performed within 90 days of enrollment and serum PSA level < 0.1ng/ml
  6. Written informed consent

Exclusion Criteria:

  1. Any evidence of metastatic disease confirmed prior to enrollment
  2. Inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5).
  3. Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer
  4. Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study
  5. Elevation of liver function tests 2x normal
  6. Contraindication to the use of LH-RH agonists or antiandrogens
  7. Active secondary malignancy (other than squamous or basal cell skin cancer) within five years prior to enrollment in study
  8. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003645

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eastern Cooperative Oncology Group
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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00003645     History of Changes
Other Study ID Numbers: ID97-077, P30CA016672, MDA-ID-97077, E-97077, NCI-T97-0069, CDR0000066733, NCI-2009-00818
Study First Received: November 1, 1999
Last Updated: June 16, 2014
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgen Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on November 25, 2014