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Completed

NCT Number: NCT00056654

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

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.

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Key information

Conditions

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

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology Centers of Alabama, Homewood, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Leuprolide Acetate

Drug

45 mg Intramuscular injection 6 month depot formulation

Primary outcomes

  1. Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.

    Time frame: Day 32 through Week 52

Secondary outcomes

  1. Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.

    Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit

  2. Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).

    Time frame: Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit

  3. Change from baseline in prostate specific antigen (PSA).

    Time frame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit

  4. Change from baseline in prostatic acid phosphatase (PAP).

    Time frame: Weeks 1, 12, 26, 40, 52 and Final Visit

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 21, 2003
Registry last updated
Sep 17, 2008

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.

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