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

April 20, 2020 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Zoladex
  • Goserelin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Disease Free Survival at 5 Years
Time Frame: Beginning of the study up to 5 years
To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years.
Beginning of the study up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Wives of the Participants Having Better Than or Equal to a "Good" Quality of Life
Time Frame: 2 years
To measure the differences in quality of life between wives of participants in the androgen ablation condition compared to wives of patients in the control condition by using quality of life assessments. The following questionnaires were completed in the clinic setting and used to assess Health related (HRQoL): Medical Outcomes Study 36-Item Short Form (SF-36), University of California-Los Angeles Sexual Function Scale (UCLA-SFS), and Southwest Oncology Group Treatment-Specific Symptoms Scale (SWOG-TSSS). The SF-36 was analysed using a composite score for each of physical health and mental health. SF-36, UCLA-SFS, SWOGTSSS were combined to classify participants' quality of life.
2 years
Quality of Life for Participants
Time Frame: 1 year
To determine the impact of one year of total androgen ablation on quality of life mentally, physically and sexual function. The following questionnaires were completed by patients in the clinic setting and used to assess HRQoL: Medical Outcomes Study 36-Item Short Form (SF-36) and University of California-Los Angeles Sexual Function Scale (UCLA-SFS). To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better quality of life.
1 year
Markers of Prognosis
Time Frame: 1 year after treatment
To obtain blood/tissue samples from patients at high risk for failure post prostatectomy to evaluate markers of prognosis.
1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
AstraZeneca
Eastern Cooperative Oncology Group

Investigators

  • Study Chair: Curtis A. Pettaway, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 14, 1999

Primary Completion (ACTUAL)

March 20, 2017

Study Completion (ACTUAL)

March 20, 2017

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 14, 2003

First Posted (ESTIMATE)

July 15, 2003

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID97-077
  • P30CA016672 (U.S. NIH Grant/Contract)
  • MDA-ID-97077 (OTHER: UT MD Anderson Cancer Center)
  • E-97077
  • NCI-T97-0069
  • CDR0000066733 (REGISTRY: NCI PDQ)
  • NCI-2009-00818 (REGISTRY: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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