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.
