NCT00176644

Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Transdermal Estradiol	application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study. The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2005-09-15
• Last updated: 2023-09-13
• Results posted: 2013-12-24

Locations

6 sites across 1 country: United States