Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
Condition: Prostate; Cancer; Hormonal Cycling
MeSH terms: Prostatic Neoplasms
Intervention: GnRH; Ketoconazole; Bicalutamide; Testosterone transdermal gel; Estrogen transdermal patch
Intervention description: leuprolide and goserelin are gonadotropin-releasing hormone analogues; An imidazole antifungal agent. reduces adrenal and testicular androgen production in men; A pure nonsteroidal antiandrogen; an androgenic anabolic steroid; Estradiol is the primary and most potent estrogen
Intervention MeSH terms: Ketoconazole; Bicalutamide; Testosterone; Estrogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate; Cancer; Hormones; 01-085; ANTIFUNGAL ANTIBIOTICS; ESTROGENS; LUPRON; TESTOSTERONE; ZOLADEX

Summary:

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

Eligibility criteria:

        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.