Status:
COMPLETED
A Study of Leuprolide to Treat Prostate Cancer
Lead Sponsor:
Abbott
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 wil...
Detailed Description
A total of 300 male subjects were planned to be enrolled. Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administer...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00626431
Start Date
February 1 2008
End Date
September 1 2009
Last Update
July 19 2011
Active Locations (63)
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1
Site Reference ID/Investigator# 8696
Birmingham, Alabama, United States, 35209
2
Site Reference ID/Investigator# 8681
Homewood, Alabama, United States, 35209
3
Site Reference ID/Investigator# 8569
Anchorage, Alaska, United States, 99508
4
Site Reference ID/Investigator# 9709
Phoenix, Arizona, United States, 85013