Intermittent Hormone Therapy in Men With Localized Prostate Cancer After Radiation Therapy or Radical Prostatectomy
Recruitment status was: Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Study of Intermittent Androgen Suppression in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy|
- PSA levels [ Time Frame: Monthly ] [ Designated as safety issue: No ]
- Quality of life, bone/body scans, blood tests [ Time Frame: Annually ] [ Designated as safety issue: No ]
|Study Start Date:||January 1997|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Intermittent Hormone Therapy
250 mg tidDrug: Leuprolide Acetate
7.5 mg q month
This study evaluates the effect of intermittent androgen suppression on time to androgen independent progression and overall survival in men with localized prostate cancer. Subjects will also be evaluated for the effects of intermittent androgen suppression on quality of life and on musculoskeletal, cardiovascular, and neuropsychiatric systems.
The subjects in this study will have a rising PSA value after definitive therapy either with radical prostatectomy or external beam irradiation for the treatment of prostate cancer. All subjects will be male, and they will be over the age of 18 years.
New subjects will be introduced to this study protocol (along with other non-study treatment options) during a clinic visit with Dr. Higano or another sub-investigator. If informed consent is obtained, subjects will undergo the following screening procedures before starting treatment: Bone density scan; bone scan; CT scan of the chest, abdomen, and pelvis; blood draw; problem solving test; quality of life and emotion questionnaires; and a body composition test. Subjects will then begin androgen suppression with a two-week lead-in of flutamide, followed by 9 monthly injections of leuprolide acetate. During the treatment, they will have quarterly clinic visits and blood draws for hematology, chemistry, liver function, and lipids. Their PSA levels are monitored monthly, and if their PSA reaches the appropriate nadir at by month 9, the androgen suppression is interrupted. At the end of each treatment cycle, subjects will undergo another bone density test, blood draw, body composition test, problem solving test, and complete the quality of life and emotion questionnaires.
During the "off treatment" phase, the subject will again have quarterly clinic visits, blood draw for chemistry, hematology, liver function, and lipids, as well as having quarterly cognitive function test. PSA and testosterone will be monitored monthly. Once the PSA reaches the appropriate threshold, the subject will perform another set of screening procedures and resume treatment for another 9 months. This cycle continues until the patient withdraws from the study, is taken off the study due to toxicities or the decision of the investigator, or if the treatment is no longer effective in controlling the prostate cancer. The problem solving tests are only performed during the subject's first cycle of treatment (consisting of the 9 months on treatment, and the entire off treatment period afterwards).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223665
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Celestia Higano, MD||University of Washington|