Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
|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.|
|ClinicalTrials.gov Identifier: NCT00003645|
Recruitment Status : Terminated (Per PI request)
First Posted : July 15, 2003
Results First Posted : April 28, 2020
Last Update Posted : April 28, 2020
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Flutamide Drug: Leuprolide Acetate||Phase 3|
- 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 (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Prospective Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence|
|Actual Study Start Date :||June 14, 1999|
|Actual Primary Completion Date :||March 20, 2017|
|Actual Study Completion Date :||March 20, 2017|
Experimental: Arm I - Leuprolide + Flutamide
Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.
10.8 mg intramuscularly once every 3 months for 12 months
Drug: Leuprolide Acetate
50 mg tablet orally daily for 12 months
No Intervention: Arm II - No Treatment
Arm II: Patients receive no initial treatment.
- 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.
- 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.
- 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.
- 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.
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
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|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|