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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00586898 |
Purpose
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Hormonal Cycling |
Drug: GnRH Drug: Ketoconazole Drug: Bicalutamide Drug: Testosterone transdermal gel Drug: Estrogen transdermal patch |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle |
| Enrollment: | 36 |
| Study Start Date: | July 2001 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: GnRH
leuprolide and goserelin are gonadotropin-releasing hormone analogues
Drug: Ketoconazole
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
Drug: Bicalutamide
A pure nonsteroidal antiandrogen
Drug: Testosterone transdermal gel
an androgenic anabolic steroid
Drug: Estrogen transdermal patch
Estradiol is the primary and most potent estrogen
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease.
B. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%
Prior hormonal therapy is allowed as:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Howard Scher, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan Kettering Cancer Center ( Howard Scher ) |
| Study ID Numbers: | 01-085 |
| Study First Received: | December 21, 2007 |
| Last Updated: | July 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00586898 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate Cancer Hormones 01-085 ANTIFUNGAL ANTIBIOTICS |
ESTROGENS LUPRON TESTOSTERONE ZOLADEX |
|
Anti-Infective Agents Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Hormones Neoplasms by Site Therapeutic Uses Antifungal Agents Estrogens |
Antineoplastic Agents, Hormonal Methyltestosterone Ketoconazole Genital Diseases, Male Pharmacologic Actions Testosterone 17 beta-cypionate Testosterone Neoplasms Anabolic Agents Androgen Antagonists Bicalutamide Prostatic Neoplasms Androgens |