Status:
COMPLETED
Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
GlaxoSmithKline
AstraZeneca
Conditions:
Cancer
Prostate Neoplasms
Eligibility:
MALE
18-100 years
Phase:
PHASE2
Brief Summary
Prostate cancer (CaP) is the most commonly diagnosed cancer among males in the U.S. and the second leading cause of cancer-related mortality. More than 230,000 men will be diagnosed with prostate canc...
Detailed Description
Androgen deprivation has been the principal means of controlling advanced prostate cancer, but does not cure the disease and all patients ultimately progress if the tumor is not eliminated with defini...
Eligibility Criteria
Inclusion
- Men 18 years or older with a histologic diagnosis of clinically localized prostate cancer prior to radical prostatectomy as defined by:
- Clinical stage T1-T2b
- Prostate specific Antigen (PSA) less than 20
- Gleason score 7-10
- Patient's tumor must be considered surgically resectable .
- Eastern Cooperative Group (ECOG) performance status of 0-1.
- Life expectancy greater than 2 years.
- Able to understand and give informed consent.
- Laboratory values must be within specified limits.
Exclusion
- Patients with locally advanced or high risk disease not meeting the criteria defined above.
- Patients who have a total testosterone less than 280 ng/dL.
- Patients who are receiving any other investigational therapy.
- Patients with an active serious infection or other serious underlying medical condition.
- Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
- Histologic evidence of small cell carcinoma of the prostate.
- Patients who are currently receiving active therapy for other neoplastic disorders.
- Patients who are receiving any androgens, estrogens or progestational agents.
- Patients who are taking drugs or herbal supplements which affect androgen metabolism (e.g., spironolactone, aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, St. John's wort).
- Patients who have chronic active hepatitis.
- Patients taking any of the following medications who cannot discontinue these medications for three months during administration of ketoconazole; statin cholesterol medications, cyclosporine, isoniazid, rifampin, terfenadine, triazolam or astemizole.
- Patients who have history of cerebrovascular accident, deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
- Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained.
- Patients unwilling to use contraceptives while on study.
- Patients with a risk of nodal involvement of greater than 10% should have received a bone scan and CT of the pelvis prior to screening for the study as part of standard of care.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00298155
Start Date
July 1 2006
End Date
January 1 2014
Last Update
August 9 2018
Active Locations (2)
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1
Veterans' Administration Puget Sound Health Care System (VAPSHCS)
Seattle, Washington, United States, 98108-1532
2
University of Washington
Seattle, Washington, United States, 98195-6158