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

March 15, 2013 updated by: Urology of Virginia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: ADT
All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.
Drug: Degarelix acetate, Leuprolide acetate
Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once
Other Names:
  • Firmagon
  • Eligard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Testosterone measurement
Time Frame: 11 times over 6 months
11 times over 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urology of Virginia

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Robert Given, MD, Urology of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (ESTIMATE)

April 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVA002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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