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

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

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

Conditions
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Prostate, Cancer, Hormonal Cycling

Intervention / Treatment
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* Drug: GnRH
* Drug: Ketoconazole
* Drug: Bicalutamide
* Drug: Testosterone transdermal gel
* Drug: Estrogen transdermal patch


Participation Criteria
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Eligibility Criteria
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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: Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: GnRH<br>* leuprolide and goserelin are gonadotropin-releasing hormone analogues<br>* Other names: ZOLADEX;Drug: Ketoconazole<br>* An imidazole antifungal agent. reduces adrenal and testicular androgen production in men<br>* Other names: Nizoral;Drug: Bicalutamide<br>* A pure nonsteroidal antiandrogen<br>* Other names: Casodex;Drug: Testosterone transdermal gel<br>* an androgenic anabolic steroid<br>* Other names: Androgel;Drug: Estrogen transdermal patch<br>* Estradiol is the primary and most potent estrogen<br>* Other names: CLIMARA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Cancer, Hormones, 01-085, ANTIFUNGAL ANTIBIOTICS, ESTROGENS, LUPRON, TESTOSTERONE, ZOLADEX