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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Urology of Virginia
ClinicalTrials.gov Identifier:
NCT01344564
First received: April 27, 2011
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Urology of Virginia:

Primary Outcome Measures:
  • Testosterone measurement [ Time Frame: 11 times over 6 months ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344564

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

No publications provided

Responsible Party: Urology of Virginia
ClinicalTrials.gov Identifier: NCT01344564     History of Changes
Other Study ID Numbers: UVA002
Study First Received: April 27, 2011
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Leuprolide
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2013