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Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003645
First Posted: July 15, 2003
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]

Enrollment: 64
Actual Study Start Date: June 14, 1999
Study Completion Date: March 20, 2017
Primary Completion Date: March 20, 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
AstraZeneca
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:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00003645     History of Changes
Other Study ID Numbers: ID97-077
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-97077 ( Other Identifier: UT MD Anderson Cancer Center )
E-97077
NCI-T97-0069
CDR0000066733 ( Registry Identifier: NCI PDQ )
NCI-2009-00818 ( Registry Identifier: NCI CTRP )
First Submitted: November 1, 1999
First Posted: July 15, 2003
Last Update Posted: March 23, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes
Leuprolide
Flutamide
Bicalutamide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists