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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Degarelix acetate, Leuprolide acetate
Sponsored by
Urology of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Hormone therapy, Testosterone measures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology of Virginia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ADT

Arm Description

All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.

Outcomes

Primary Outcome Measures

Testosterone measurement

Secondary Outcome Measures

Full Information

First Posted
April 27, 2011
Last Updated
March 15, 2013
Sponsor
Urology of Virginia
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01344564
Brief Title
Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide
Official Title
Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urology of Virginia
Collaborators
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Hormone therapy, Testosterone measures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADT
Arm Type
Other
Arm Description
All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.
Intervention Type
Drug
Intervention Name(s)
Degarelix acetate, Leuprolide acetate
Other Intervention Name(s)
Firmagon, Eligard
Intervention Description
Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once
Primary Outcome Measure Information:
Title
Testosterone measurement
Time Frame
11 times over 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Given, MD
Organizational Affiliation
Urology of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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