Completed
PHASE2
INTERVENTIONAL
NCT00586898
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
Interventions
Name:
GnRH
Type:
DRUG
Description:
leuprolide and goserelin are gonadotropin-releasing hormone analogues
Name:
Ketoconazole
Type:
DRUG
Description:
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
Name:
Bicalutamide
Type:
DRUG
Description:
A pure nonsteroidal antiandrogen
Name:
Testosterone transdermal gel
Type:
DRUG
Description:
an androgenic anabolic steroid
Name:
Estrogen transdermal patch
Type:
DRUG
Description:
Estradiol is the primary and most potent estrogen
Primary Outcomes
Measure:
Response
TimeFrame:
6 months
Description:
Complete Response: Normalization of the PSA (\< or = to 4.0 for patients with castrate metastatic disease, or \< 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by \> or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.
Trial Information
NCT ID
NCT00586898
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Memorial Sloan Kettering Cancer Center
Last Updated
December 15, 2025