Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy

September 18, 2006 updated by: PRAECIS Pharmaceuticals Inc.

Phase 2 Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy

This is a Phase 2, open-label study in subjects with androgen-independent prostate cancer who have progressed following treatment with an LHRH agonist. Up to 22 subjects will be enrolled. Enrollment will be monitored to ensure that not all subjects are enrolled based on rising prostate specific antigen (PSA) criterion only.

Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks for 12 weeks (total dose of 600 mg).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Mesa, California, United States, 91942
        • San Diego Center for Urology
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Southwest Florida Urological Associates
      • Panama City, Florida, United States, 32405
        • Panama City Urological Center
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Columbus Urology Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Health & Science University
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604-3200
        • Urological Associates of Lancaster
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Signed informed consent

  • Histologically or cytologically confirmed prostate cancer that has progressed within 60 days of the start of screening despite castrate levels of testosterone from treatment with an LHRH agonist. Progression will be defined as one or more of the following: *A rising PSA, defined as at least two consecutive rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least one week after PSA #1. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2, OR

    • The appearance of new metastatic lesions on a bone scan, OR
    • Progression of known lesions or the appearance of new metastatic lesions on CT, MRI, chest x-ray, or other radiographic evaluations.
  • Subject whose hormonal therapy includes an anti-androgen must have the anti-androgen discontinued prior to the start of screening (at least 6 weeks for bicalutamide and at least 4 weeks otherwise). If there is a reduction in the PSA after anti-androgen withdrawal, the subject must continue to demonstrate progression as defined above after anti- androgen withdrawal to be eligible.
  • ECOG Performance Status ≤ 3
  • Age ≥ 18 years of age
  • Life expectancy ≥ 6 months
  • Serum testosterone less than or equal to 50 ng/dL
  • PSA ≥ 5 ng/mL (if progression is determined from a rise in PSA)
  • WBC greater than or equal to 3,000/mm3
  • Hematocrit ≥ 30%
  • Platelet count greater than or equal to 100,000/mm3
  • Serum creatinine less than or equal to 2 x upper limit of normal (ULN)
  • Bilirubin (direct or total) less than or equal to 2 x ULN
  • SGPT (ALT) and SGOT (AST) less than or equal to 2 x ULN

Exclusion Criteria:

A subject is ineligible to participate in the study if he meets any of the following criteria:

  • Prior treatment for prostate cancer with:

    • Chemotherapy
    • Radiopharmaceutical such as strontium or samarium
    • Diethylstilbesterol or another estrogen agonist or antagonist
    • Ketoconazole
    • Aminoglutethimide
  • Current treatment with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medication
  • Currently taking PC SPES
  • History of allergy to a LHRH agonist or GnRH antagonist
  • Major surgery within 4 weeks
  • Serious medical illnesses, including malnutrition, that in the judgment of the investigator would preclude protocol treatment
  • Significant cardiovascular illness defined as NYHA class III or IV congestive heart failure or unstable angina within 6 months, myocardial infarction within 12 months, deep venous thrombosis within 2 years, or any history of acute pulmonary embolism
  • Active second malignancy other than non-melanoma skin cancer or superficial bladder cancer
  • Any uncontrolled infection, including HIV
  • Any other experimental therapy within 4 weeks prior to study entry
  • QTc > 450 msec on a screening ECG obtained by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical adverse events, laboratory abnormalities, and withdrawals due to adverse events
Serum FSH levels below the lower limit of quantitation (LLOQ) on Days 57 and 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PRAECIS Pharmaceuticals Inc.

Investigators

  • Study Director: Marc Garnick, MD, PRAECIS Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

December 27, 2004

First Submitted That Met QC Criteria

December 27, 2004

First Posted (Estimate)

December 28, 2004

Study Record Updates

Last Update Posted (Estimate)

September 19, 2006

Last Update Submitted That Met QC Criteria

September 18, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149-04-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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