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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Degarelix acetate, Leuprolide acetate

Drug

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

Other names: Firmagon, Eligard

Primary outcomes

Testosterone measurement

Time frame: 11 times over 6 months

Sponsors and collaborators

Lead sponsor

Urology of Virginia

Other

Collaborators

Ferring Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Apr 29, 2011
Registry last updated: Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed