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Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
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.
Age
18 - No limit years
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
Start Date
May 1, 2005
Primary Completion Date
December 1, 2008
Completion Date
December 1, 2008
Last Updated
September 13, 2023
23
ACTUAL participants
Transdermal Estradiol
DRUG
Lead Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
NCT06842498
NCT04550494
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05691465