Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer

Completed · Phase 2

Conditions studied: Cancer, Prostate Neoplasms

In brief

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 disease. Androgen deprivation, the elimination of testosterone and its active metabolites, remains the single most effective intervention available for the treatment of advanced prostate carcinoma. Androgen deprivation induces an immune response to normal prostate and prostate cancer, which is usually short-lived. Estradiol induces activation of many arms of the immune system and may be a more effective and long lasting means of inducing immunity to prostate tissue. This study will treat clinically localized prostate cancer patients with either estrogens, or standard androgen deprivation without estrogens, prior to prostatectomy in order more completely to describe immune regulation by estradiol in men. Control tissue from patients who have not been treated with androgen deprivation will be procured from the Northwest Special Projects in Oncology Research Excellence (SPORE) tissue core and used as comparisons against the cancers treated before prostatectomy. Tumors removed at prostatectomy, tissue samples and blood samples will be assessed for immune system changes.

Key facts

Study ID

NCT00167648

Run by

University of Washington

People needed

17

Starts

2005-03-01

Expected to finish

2006-12-01

Last updated by the study team

2009-01-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• VA Puget Sound Health Care System — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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