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Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00100243•PRAECIS Pharmaceuticals Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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)
+6 more criteria

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
+7 more criteria

Locations (7)

San Diego Center for Urology

La Mesa, California, United States

Southwest Florida Urological Associates

Fort Myers, Florida, United States

Panama City Urological Center

Panama City, Florida, United States

Columbus Urology Research, LLC

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Urological Associates of Lancaster

Lancaster, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Key Dates

Start Date

May 1, 2004

Completion Date

September 1, 2005

Last Updated

September 19, 2006

Enrollment

Estimated participants

Conditions

Prostate Cancer

Interventions

Plenaxis

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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