Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy
NCT ID: NCT00100243
Last Updated: 2006-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2004-05-31
2005-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks for 12 weeks (total dose of 600 mg).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Plenaxis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PRAECIS Pharmaceuticals Inc.
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc Garnick, MD
Role: STUDY_DIRECTOR
PRAECIS Pharmaceuticals Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
149-04-01
Identifier Type: -
Identifier Source: org_study_id