A Prospective Study of Intermittent Androgen Suppression in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy
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).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA levels
Monthly
No
Celestia Higano, MD
Principal Investigator
University of Washington
United States: Institutional Review Board
30296-A
NCT00223665
January 1997
December 2014
Name | Location |
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Seattle Cancer Care Alliance | Seattle, Washington 98109 |