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

Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00056654

Enrollment

164

Registered

2003-03-21

Start date

2003-03-31

Completion date

2004-07-31

Last updated

2008-09-17

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

Conditions

Prostatic Neoplasms

Keywords

Leuprolide, Prostatic Neoplasms, Testosterone, Prostate-specific Antigen, Pharmacokinetics, luprolide acetate

Brief summary

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.

Detailed 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.

Interventions

DRUGLeuprolide acetate

45 mg Intramuscular injection 6 month depot formulation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

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

Design outcomes

Primary

Measure	Time frame
Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.	Day 32 through Week 52

Secondary

Measure	Time frame
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.	Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit
Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).	Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit
Change from baseline in prostate specific antigen (PSA).	Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
Change from baseline in prostatic acid phosphatase (PAP).	Weeks 1, 12, 26, 40, 52 and Final Visit

Countries

United States

Outcome results

None listed

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