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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586898
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Hormonal Cycling Drug: GnRH Drug: Ketoconazole Drug: Bicalutamide Drug: Testosterone transdermal gel Drug: Estrogen transdermal patch Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
Study Start Date : July 2001
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Response [ Time Frame: 6 months ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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%

  • 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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00586898

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Principal Investigator: Howard Scher, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00586898     History of Changes
Other Study ID Numbers: 01-085
First Posted: January 7, 2008    Key Record Dates
Results First Posted: March 25, 2016
Last Update Posted: March 25, 2016
Last Verified: February 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors