A Study of Leuprolide to Treat Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Leuprolide acetate - Formulation A; Leuprolide acetate - Formulation B
Intervention description: Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart.; Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.
Intervention MeSH terms: Leuprolide; Hormones; Prolactin Release-Inhibiting Factors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 310.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupron Depot; prostate cancer; leuprolide acetate

Summary:

      To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month
      depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A
      formulation will be deemed successful if the percentage of subjects with suppression of
      testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of
      the 2-sided 90% confidence interval), a protocol-specified criterion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily sign an IRB-approved informed consent form and any required privacy
             statement/authorization form.

          -  Pre-trial serum testosterone level >150 ng/dL.

          -  Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or
             D and TNM* classification cT1b-4, N: any, M: any.

             *Tumor/Nodes/Metastases

          -  Subjects with a rising PSA following radical prostatectomy defined as an increase of
             0.2 ng/mL from the previous test on two consecutive testings or rising PSA following
             prostate irradiation using Phoenix Definition of a rise of greater than or equal to
             2.0 ng/mL above the nadir.

          -  Prostate cancer and general clinical status is sufficient to warrant at least 48 weeks
             of continuous androgen deprivation treatment, without concomitant antiandrogen
             treatment.

          -  Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2 at the
             time of pre-trial screening.

          -  Life expectancy of at least 18 months.

          -  Subjects with serum creatinine ≤1.9 mg/dL, bilirubin ≤2.0 mg/dL (unless Gilbert's
             syndrome with normal AST, ALT); AST and ALT ≤2.5 times the upper limit of normal.

        Exclusion Criteria:

          -  Requires additional treatment including radical prostatectomy, radiotherapy or
             cryotherapy of local disease.

          -  Historical, clinical, or radiographic evidence of central nervous system metastases,
             including spinal cord metastasis.

          -  Clinical evidence of urinary tract obstruction.

          -  History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.

          -  History of clinical hypogonadism.

          -  Current malignancy or history of malignancy except for prostate cancer or basal or
             squamous cell carcinoma of the skin.

          -  Clinical or laboratory evidence of any severe underlying disease state (excluding
             prostate cancer) that would place subjects in additional jeopardy by participating in
             this trial.

          -  Hypersensitivity to leuprolide, polylactic acid, or any excipient of the drug.

          -  Incomplete recovery from the effects of any major surgery.

          -  History of receiving of the following prostate cancer therapies within 8 weeks prior
             to the Screening Visit: chemotherapy, immunotherapy, antiandrogen, radiation therapy,
             cryotherapy, strontium, or biological response modifiers.

          -  History of prostatic surgery within 4 weeks prior to the Screening Visit.

          -  Received hormonal therapy, including GnRH analogs (less than or equal to 6 month depot
             administration), estrogen, Megace and phytotherapy, within 32 weeks prior to the
             Screening Visit and during the trial.

          -  Alternative medical therapies which have an estrogenic, androgenic, or antiandrogenic
             effect (including phyto-estrogens and phyto-androgens) within 12 weeks prior to the
             Screening Visit and during the trial.

          -  Requires the chronic use of systemic corticosteroids and anticonvulsants that may
             affect bone loss such as carbamazepine, phenobarbital, phenytoin, valproic acid or
             primidone.

          -  May require antiandrogen, immuno-, or surgical therapy for prostate cancer during the
             trial.

          -  History of alcoholism or consumes >14 alcoholic beverages per week or illicit drug
             abuse within 12 months prior to screening.

          -  Received therapy with a GnRH analog (1 year implant) within 60 weeks prior to the
             Screening Visit.

          -  Received therapy with finasteride or ketoconazole within 1 week prior to the Screening
             Visit; dutasteride within 25 weeks prior to the Screening Visit.