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

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00586898
First received: December 21, 2007
Last updated: July 9, 2009
Last verified: July 2009
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer. [ Time Frame: completion of study ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2001
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: GnRH
leuprolide and goserelin are gonadotropin-releasing hormone analogues
Other Names:
  • LUPRON
  • ZOLADEX
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00586898

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

Additional Information:
No publications provided

Responsible Party: Howard Scher, Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00586898     History of Changes
Other Study ID Numbers: 01-085
Study First Received: December 21, 2007
Last Updated: July 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Prostate
Cancer
Hormones
01-085
ANTIFUNGAL ANTIBIOTICS
ESTROGENS
LUPRON
TESTOSTERONE
ZOLADEX

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Bicalutamide
Goserelin
Antifungal Agents
Ketoconazole
Estrogens
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014