Last updated on July 2008

Prostate Cancer - Adult Men

Brief description of study

Prostate Cancer - Adult Men

Detailed Study Description

Men with prostate cancer are asked to participate in a research study being conducted by Jacobi Medical Center.

Patient Inclusion Criteria
You may be eligible to participate in this study if you:

  • Are a male at least 18 years of age
  • Have been diagnosed with prostate cancer

Patient Exclusion Criteria
You may not participate in this study if you:

  • Have a history or evidence of central nervous system cancer or spinal cancer.
  • Have urinary tract obstruction.
  • Have a history of bilateral orchiectomy, adrenalectomy, hypophysectomy or hypogonadism.
  • Have current malignancy or history of malignancy within 5 years prior to screening with the exception of the following:
    • Prostate cancer
    • Treated basal or skin cancer
  • Allergic to leuprolide, polylactic acid
  • Have incomplete recovery from a major surgery
  • Have had the following prostate cancer therapies within 8 weeks prior to the Screening Visit:
    • Chemotherapy
    • Immunotherapy
    • Antiandrogen
    • Radiation therapy (EBRT, 3D-CRT, IMRT, PBRT or brachytherapy)
    • Cryotherapy
    • Strontium
    • Biological response modifiers
  • Have a history of prostatic surgery (includes transurethral resection of prostate [TURP] and radical prostatectomy) within 4 weeks prior to the Screening Visit
  • Have had hormonal therapy
  • Use alternative medical therapies which have an estrogenic, androgenic, or antiandrogenic effect within 12 weeks prior to the Screening Visit and through the Treatment Period
  • Have been exposed to finasteride or ketoconazole within 1 week prior to the Screening Visit and through the Treatment Period; dutasteride within 25 weeks prior to the Screening Visit and through the Treatment Period
  • Require the chronic use of systemic corticosteroids or anticonvulsants that may affect bone loss such as carbamazepine, phenobarbital, phenytoin, valproic acid or primidone
  • Consume more than 14 alcoholic beverages per week or history of alcoholism or illicit drug abuse within the 12 months prior to Screening
  • Have participated in another research study within the last 30 days

Clinical Study Identifier: TX134380


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Maria Chiodi

Biomedical Research Alliance of New York
Bronx, NY USA
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