Status:
COMPLETED
Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Pacific Northwest SPORE
Conditions:
Cancer
Prostate Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Prostate cancer is the most commonly diagnosed cancer among males in the U.S. More than 220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000 will die of this di...
Detailed Description
Estrogens are effective means of treating advanced prostate cancer. In randomized studies estrogens have better cancer control rates than orchiectomy alone, suggesting that estrogen efficacy is not li...
Eligibility Criteria
Inclusion
- Men 18 years or older with a histologic diagnosis of low to intermediate risk prostate cancer prior to radical prostatectomy as defined by:
- Clinical stage T1-T2b
- PSA \< 20
- Gleason score \< 7
- Patients who have more than one of the following prognostic factors: T2b, Gleason 7, PSA 10-20 are not eligible.
- Patient's tumor must be considered surgically resectable as determined by a urologic evaluation
- ECOG performance status of 0-1
- Life expectancy greater than 2 years
- Able to understand and give informed consent
- Patients must agree not to take dietary phytoestrogens or other estrogen containing supplements
Exclusion
- Patients with locally advanced or high-risk disease as defined above.
- Patients who have a testosterone less than 280 ng/dL.
- Patients who have evidence of cerebrovascular accident or ischemia, recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
- Patients who are receiving any other investigational therapy.
- Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
- Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
- Patients with immunodeficiency or on oral corticosteroids
- Histologic evidence of small cell carcinoma of the prostate.
- Patients with a prior history of myocardial infarction, pulmonary embolism, CVA or atrial fibrillation.
- Patients with active thrombophlebitis.
- Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent.
- Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained
- Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible for study.
- Patients taking any of the following medications who cannot discontinue these medications for three weeks during administration of androgen deprivation: aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, St. John's wort.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00167648
Start Date
March 1 2005
End Date
December 1 2006
Last Update
January 19 2009
Active Locations (2)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98119
2
University of Washington Medical Center
Seattle, Washington, United States, 98195-6158