Official Title: “Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle”

Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
  • Time Frame: completion of study
    Safety Issue?: 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%
• Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.
• Patient must have level of serum testosterone above the lower limit of normal.
• Karnofskcy performance status (KPS) >_70%.
• Patients must have adequate organ function as defined by the following laboratory criteria:
• WBC >_3500/mm3, platelet count >_100,000/mm3.
• Bilirubin <2.0 mg/dl or SGOT <3.0 X the upper limit of normal.
• Creatinine <_1.6 mg/dl or creatinine clearance >_60 cc/min.
• Prior hormonal therapy is allowed as:
• 1. Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months.
• 2. One cycle of intermittent therapy up to a maximum exposure of 10 months.
• Patients must be at least 18 years of age.
• Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment

Exclusion Criteria:

• Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease.
• Uncontrolled serious active infection.
• Anticipated survival of less than 3 months.
• Active CNS or epiduraltumor
• Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Howard Scher, MD Principal Investigator Memorial Sloan-Kettering Cancer Center  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00586898

Study ID Number: 01-085

ClinicalTrials.gov Identifier: NCT00586898

Health Authority: United States: Food and Drug Administration

Memorial Sloan-Kettering Cancer Center