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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01344564

Enrollment

Registered

2011-04-29

Start date

2011-04-30

Completion date

2012-08-31

Last updated

2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Hormone therapy, Testosterone measures

Brief 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.

Interventions

DRUGDegarelix acetate, Leuprolide acetate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Testosterone measurement	11 times over 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026