Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Transdermal Estradiol

• Registration Number: NCT00176644
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2013-11-05
• Results First Submitted QC: 2013-11-05
• Results First Posted: 2013-12-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transdermal estradiol	Transdermal Estradiol	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With PSA Response	3 years	PSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention.

Secondary Outcome Measures

Name	Time	Method
Measurable Disease Response Assessment in Participants With Hormone and Chemotherapy Refractory Prostate Cancer	4 years
To Measure Quality of Life of Participants Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).	3 years
Time to Progression	3 years
Plateau Level of Estradiol and Testosterone Response in Androgen-Resistant Population With 0.4mg/Day Transdermal Estradiol Patch	3 years

Trial Locations

Locations (6)

Robert Wood Johnson University Hospital/CINJ at Hamilton; 🇺🇸 Hamilton, New Jersey, United States

Saint Peter's University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

CentraState Healthcare System; 🇺🇸 Freehold, New Jersey, United States

Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Morristown Memorial Hospital; 🇺🇸 Morristown, New Jersey, United States

Overlook Hospital; 🇺🇸 Summit, New Jersey, United States