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

Urology of Virginia

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: Degarelix acetate, Leuprolide acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01344564

UVA002

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ADT

Other group

Description:

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

Treatment:

Drug: Degarelix acetate, Leuprolide acetate