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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100243
Recruitment Status : Completed
First Posted : December 28, 2004
Last Update Posted : September 19, 2006
Information provided by:
PRAECIS Pharmaceuticals Inc.

December 27, 2004
December 28, 2004
September 19, 2006
May 2004
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  • 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
Same as current
Complete list of historical versions of study NCT00100243 on Archive Site
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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

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).

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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: Plenaxis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2005
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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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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PRAECIS Pharmaceuticals Inc.
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Study Director: Marc Garnick, MD PRAECIS Pharmaceuticals Inc.
PRAECIS Pharmaceuticals Inc.
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP