Intermittent Hormone Therapy in Men With Localized Prostate Cancer After Radiation Therapy or Radical Prostatectomy
Summary
Sometimes blood levels of prostatic specific antigen (PSA) will rise in men who have had prostate surgery or received radiation therapy for localized prostate cancer. A low value for the PSA is more desirable as is may indicate no tumor growth. Giving the hormone therapy intermittently (in cycles of treatment and off treatment periods) appears to delay the change of prostate cancer to a type of prostate cancer that resists hormone therapy. If it does, the prostate cancer will be treatable for a longer period of time, as well as improve the quality of life. Mental functioning is monitored during therapy to see if this treatment has any impact on memory or ability to carry out tasks. In addition, extra tubes of blood are obtained to test for Amyloid-B protein (AB protein) whose presence may be associated with problem solving decline.
Description
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).
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Prostate Cancer
Intervention
Flutamide, Leuprolide Acetate
Location
Seattle Cancer Care Alliance
Seattle
Washington
United States
98109
Status
Recruiting
Source
University of Washington
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00223665
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Prostate-specific Antigen
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
Megestrol Acetate
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
Megestrol
17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione. A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.
Fenretinide
A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
Ultrasound, High-intensity Focused, Transrectal
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
Clinical Trials
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PubMed Articles
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