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Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide

Information source: Urology of Virginia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Degarelix acetate, Leuprolide acetate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Urology of Virginia

Official(s) and/or principal investigator(s):
Robert Given, MD, Principal Investigator, Affiliation: Urology of Virginia

Summary

The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.

Clinical Details

Official title: Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Testosterone measurement

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 18 years or older

- Histologically confirmed adenocarcinoma of the prostate

- Androgen deprivation therapy is indicated

Exclusion Criteria:

- Baseline screening serum testosterone <150ng/dL

- Eastern Cooperative Oncology Group (ECOG) score > 2

- Diagnosed spinal or brain metastases

- Hormonal manipulation within previous 6 months

Locations and Contacts

Urology of Virginia, Virginia Beach, Virginia 23462, United States
Additional Information

Starting date: April 2011
Last updated: March 15, 2013

Page last updated: August 23, 2015

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