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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344564
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : March 18, 2013
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Urology of Virginia

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix acetate, Leuprolide acetate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate
Study Start Date : April 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Testosterone measurement [ Time Frame: 11 times over 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01344564

United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Urology of Virginia
Ferring Pharmaceuticals
Principal Investigator: Robert Given, MD Urology of Virginia

Responsible Party: Urology of Virginia Identifier: NCT01344564     History of Changes
Other Study ID Numbers: UVA002
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013

Keywords provided by Urology of Virginia:
Prostate cancer
Hormone therapy
Testosterone measures

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents