Spots Global Cancer Trial Database for A Phase II Trial of Phenoxodiol in Patients With Castrate and Non-Castrate Prostate Cancer
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Trial Identification
Brief Title: A Phase II Trial of Phenoxodiol in Patients With Castrate and Non-Castrate Prostate Cancer
Official Title: A Phase II Trial of Phenoxodiol in Patients With Castrate and Non-Castrate Prostate Cancer
Study ID: NCT00557037
Conditions
Interventions
Study Description
Brief Summary: Two groups of patients with prostate cancer will be enrolled: Group A: patients whose cancer has worsened or spread after being on hormonal therapy and has not had any chemotherapy. Group B: patients who have a rising PSA after surgery or radiotherapy for the prostate and do not have any spread to the bones or other organs. Patients will receive Phenoxodiol (PXD) 400 mg every 8 hours daily for 28 consecutive days (1 cycle). Treatment outcome will be evaluated after three cycles (12 weeks) of PXD treatment (immediately prior to cycle 4). Patients with progression of disease will be taken off study. Responding and stable disease patients will remain on study for a total of 12 cycles(approximately 12 months).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Yale Cancer Center, New Haven, Connecticut, United States
VA Connecticut Healthcare System, West Haven, Connecticut, United States
Contact Details
Name: Kevin Kelly, MD
Affiliation: Yale New Haven Hospital
Role: PRINCIPAL_INVESTIGATOR
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