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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

Phase 3
45 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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

This study is an open-label, multi-center study in which a minimum of 165 patients will
receive one (1) of three (3) lots of Oakwood Laboratories' Leuprolide Acetate for Injectable
Suspension 22.5 mg for two cycles. A subset of patients (minimum of 12) will be assigned to
each lot (A, B or C) and will have additional blood sampling to characterize leuprolide
release kinetics for each dose administered.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The percentage of responders who attain and maintain castrate levels of serum testosterone

Outcome Time Frame:

From Day 28 to Day 168.

Safety Issue:


Principal Investigator

Daniel Saltzstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Urology San Antonio Research PA


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

August 2008

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Oakwood Laboratories, LLC Oakwood Village, Ohio  44146