A Phase 3, Open-Label, Multi-Center, Safety And Efficacy Study of Oakwood Laboratories' Leuprolide Acetate For Injectable Suspension 22.5 mg In Patients With Prostate Cancer
Inclusion Criteria:
- Reads, understands and is able and willing to sign informed consent form
- Males greater than or equal to age 45
- Histologically and cytologically documented prostate carcinoma
- Candidate for initial hormone therapy - inclusive of patients beginning neoadjuvant
or intermittent therapy, being treated locally for advanced disease, or patients
beginning therapy for failure of prior local therapy
- Patients who have had prior LHRH therapy in an adjuvant or neoadjuvant setting,
providing that the last date of effective therapy was greater than 6 months prior to
screening
- ECOG 0-2
- Morning serum testosterone level > 150 ng/dL
- Standard screening labs within 2x ULN (AST, ALT, bilirubin and serum creatinine)
- Hemoglobin > 10 g/dL
- Life expectancy of >1yr.
- Willing to complete both cycles and all procedures of the study
Exclusion Criteria:
- Any prior (except for prior LHRH therapy in an adjuvant or neoadjuvant setting) or
current definitive therapy for prostate cancer, including chemotherapy,
immunotherapy, tumor-vaccines,biological response modifiers, or estrogens
- Patients who have undergone any prostatic surgery within 4 weeks of Baseline
- Patients who have undergone orchiectomy, adrenalectomy, or hypophysectomy
- Patients that are currently hospitalized or require frequent hospitalization
- Prior resistance to LHRH therapy, either neoadjuvant or adjuvant.
- Patients with evidence of spinal cord compression, ureteral obstruction or clinically
significant bladder outlet obstruction
- Participation in any investigational drug, biologic, or device study within five
half-lives of its physiological action or three months prior to enrollment, whichever
was longer
- Patients anticipated to need concomitant hormonal, anti-androgen, radio-, chemo-,
immuno- or surgical therapy for prostate cancer while on study
- History of recent drug and/or alcohol abuse within 6 months of screening
- History of HIV, HCV or HBV infection
- History of hypersensitivity or known allergy to LHRH agonists or antagonists
- Concurrent use of daily corticosteroids or other agents known to modify serum
androgen within 12 weeks of screening visit
- Patients on other anti-androgens such as flutamide, nilutamide or bicalutamide
- History of other cancer with the exception of non-metastatic basal or squamous cell
carcinoma of the skin
- Patients receiving any type of 5-alpha reductase inhibitor such as Proscar, Propecia,
or Avodart within the past 3 months
- Patients who have experienced a myocardial infarction, unstable or uncontrolled
cardiovascular disease or a coronary vascular procedure within 6 months of Baseline
- Patients who have experienced venous thrombosis within 6 months of Baseline
- Patients with other serious intercurrent illness(es) or disease(s)that might
interfere with, or put them at additional risk for, their ability to receive the
treatment outlined in the protocol
- Patients who have a history of the following: Immunization within 4 weeks of
Baseline; Flu shots within 2 weeks of Baseline; Donation or receipt of blood or blood
products within 2 months of Baseline; Anaphylaxis
- Patients who have received Oakwood's leuprolide acetate formulation previously.