|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
Drug: GnRH
leuprolide and goserelin are gonadotropin-releasing hormone analogues
Other Names:
Drug: Ketoconazole
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
Other Name: Nizoral
Drug: Bicalutamide
A pure nonsteroidal antiandrogen
Other Name: Casodex
Drug: Testosterone transdermal gel
an androgenic anabolic steroid
Other Name: Androgel
Drug: Estrogen transdermal patch
Estradiol is the primary and most potent estrogen
Other Name: CLIMARA
|
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: | Howard Scher, Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00586898 History of Changes |
| Other Study ID Numbers: | 01-085 |
| Study First Received: | December 21, 2007 |
| Last Updated: | July 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate Cancer Hormones 01-085 ANTIFUNGAL ANTIBIOTICS |
ESTROGENS LUPRON TESTOSTERONE ZOLADEX |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Bicalutamide Goserelin Antifungal Agents |
Ketoconazole Estrogens Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |