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

NCT ID: NCT01344564

Last Updated: 2013-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADT

All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.

Group Type OTHER

Degarelix acetate, Leuprolide acetate

Intervention Type DRUG

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

Interventions

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Degarelix acetate, Leuprolide acetate

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

Intervention Type DRUG

Other Intervention Names

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Firmagon Eligard

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Urology of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Given, MD

Role: PRINCIPAL_INVESTIGATOR

Urology of Virginia

Locations

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Urology of Virginia

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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UVA002

Identifier Type: -

Identifier Source: org_study_id

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