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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344564
• Other study ID #: UVA002
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: March 15, 2013
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2013
• Source: Urology of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix acetate, Leuprolide acetate
Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once

Locations

Country	Name	City	State
United States	Urology of Virginia	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Urology of Virginia	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosterone measurement		11 times over 6 months	No