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Brief Title: Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer
Official Title: Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
Study ID: NCT00176644
Brief Summary: Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
CentraState Healthcare System, Freehold, New Jersey, United States
Robert Wood Johnson University Hospital/CINJ at Hamilton, Hamilton, New Jersey, United States
Morristown Memorial Hospital, Morristown, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
Name: Mark Stein, MD
Affiliation: Rutgers, The State University of New Jersey
Role: PRINCIPAL_INVESTIGATOR