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

NCT01344564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Degarelix acetate, Leuprolide acetate

Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Urology of Virginia

    lead OTHER

Principal Investigators

  • Robert Given, MD · Urology of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344564 on ClinicalTrials.gov