A Study of Leuprolide to Treat Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00626431

Run by

Abbott

People needed

310

Starts

2008-02-01

Expected to finish

2009-09-01

Last updated by the study team

2011-07-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 8681 — Homewood, Alabama, United States
• Site Reference ID/Investigator# 8569 — Anchorage, Alaska, United States
• Site Reference ID/Investigator# 9709 — Phoenix, Arizona, United States
• Site Reference ID/Investigator# 8662 — Sierra Vista, Arizona, United States
• Site Reference ID/Investigator# 8656 — Tucson, Arizona, United States
• Site Reference ID/Investigator# 9705 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 8691 — Anaheim, California, United States
• Site Reference ID/Investigator# 8566 — Atherton, California, United States
• Site Reference ID/Investigator# 8686 — Fresno, California, United States
• Site Reference ID/Investigator# 8698 — Laguna Hills, California, United States
• Site Reference ID/Investigator# 9703 — Long Beach, California, United States
• Site Reference ID/Investigator# 8674 — Los Angeles, California, United States
• Site Reference ID/Investigator# 8650 — Tarzana, California, United States
• Site Reference ID/Investigator# 8699 — Torrance, California, United States
• Site Reference ID/Investigator# 8668 — Denver, Colorado, United States
• Site Reference ID/Investigator# 8646 — Englewood, Colorado, United States
• Site Reference ID/Investigator# 8652 — Middlebury, Connecticut, United States
• Site Reference ID/Investigator# 8697 — New Britain, Connecticut, United States
• Site Reference ID/Investigator# 8655 — Aventura, Florida, United States
• Site Reference ID/Investigator# 8648 — Daytona Beach, Florida, United States
• Site Reference ID/Investigator# 8660 — New Smyrna Beach, Florida, United States
• Site Reference ID/Investigator# 8658 — Orange City, Florida, United States
• Site Reference ID/Investigator# 8664 — Orlando, Florida, United States
• Site Reference ID/Investigator# 8651 — Saint Augustine, Florida, United States
• Site Reference ID/Investigator# 8696 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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