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

NCT00100243 | Completed Phase 2

• 1 other identifier: 149-04-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 7

Brief Summary

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).

Conditions

Prostate Cancer

Keywords

androgen-independent; prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Plenaxis DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PRAECIS Pharmaceuticals Inc.: lead

Study Sites (7)

San Diego Center for Urology

La Mesa, California, 91942, United States

Location

Southwest Florida Urological Associates

Fort Myers, Florida, 33907, United States

Location

Panama City Urological Center

Panama City, Florida, 32405, United States

Location

Columbus Urology Research, LLC

Columbus, Ohio, 43214, United States

Location

Oregon Health & Science University

Portland, Oregon, 97201-3098, United States

Location

Urological Associates of Lancaster

Lancaster, Pennsylvania, 17604-3200, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abarelix

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Garnick, MD

  PRAECIS Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 27, 2004
• First Posted: December 28, 2004
• Study Start: May 1, 2004
• Study Completion: September 1, 2005
• Last Updated: September 19, 2006

Record last verified: 2006-09

Locations

US (7)