Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer

Abbott

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Drug: Leuprolide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00056654

C02-008

Details and patient eligibility

About

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.

Full description

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.

Enrollment: 164 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of prostate cancer
• Need for androgen deprivation treatment for 1 year
• Serum testosterone level ≥ 150 ng/dL
• Life expectancy of at least 18 months
• ECOG Performance status grades 0,1 or 2

Exclusion criteria

• Hypersensitivity to leuprolide acetate or polylactic acid
• History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
• History of hypogonadism

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Leuprolide acetate