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

This study has been completed.
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Urology of Virginia Identifier:
First received: April 27, 2011
Last updated: March 15, 2013
Last verified: March 2013
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 Intervention
Prostate Cancer Drug: Degarelix acetate, Leuprolide acetate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Urology of Virginia:

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

Enrollment: 50
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Urology of Virginia Identifier: NCT01344564     History of Changes
Other Study ID Numbers: UVA002
Study First Received: April 27, 2011
Last Updated: March 15, 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 processed this record on August 16, 2017