Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
NCT ID: NCT00586898
Last Updated: 2016-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2001-07-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
GnRH
leuprolide and goserelin are gonadotropin-releasing hormone analogues
Ketoconazole
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
Bicalutamide
A pure nonsteroidal antiandrogen
Testosterone transdermal gel
an androgenic anabolic steroid
Estrogen transdermal patch
Estradiol is the primary and most potent estrogen
Interventions
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GnRH
leuprolide and goserelin are gonadotropin-releasing hormone analogues
Ketoconazole
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
Bicalutamide
A pure nonsteroidal antiandrogen
Testosterone transdermal gel
an androgenic anabolic steroid
Estrogen transdermal patch
Estradiol is the primary and most potent estrogen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
MALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Howard Scher, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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01-085
Identifier Type: -
Identifier Source: org_study_id
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