Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
Information source: Memorial Sloan-Kettering Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate; Cancer; Hormonal Cycling
Intervention: GnRH (Drug); Ketoconazole (Drug); Bicalutamide (Drug); Testosterone transdermal gel (Drug); Estrogen transdermal patch (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
Howard Scher, MD, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center
Summary
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate
prostate cancer.
Clinical Details
Official title: Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information
Memorial Sloan-Kettering Cancer Center
Starting date: July 2001
Ending date: December 2008
Last updated: March 18, 2008
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