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A Study of Leuprolide 45 mg Formulation to Treat Prostate Cancer
This study has been completed.
First Received: February 20, 2008   Last Updated: September 30, 2009   History of Changes
Sponsor: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00626431
  Purpose

The purpose of this study is to access the efficacy and safety of two new formulations of leuprolide acetate 45 mg 6-month depot formulations in treating patients with prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: Leuprolide acetate formulation A
Drug: Leuprolide acetate formulation B
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month Leuprolide Formulations, in Subjects With Prostatic Adenocarcinoma.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • The suppression of serum testosterone (≤50 ng/dL) from Week 4 through Week 48. [ Time Frame: Week 4 through Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Prostate Specific antigen (PSA) levels. [ Time Frame: At each treatment visit ] [ Designated as safety issue: No ]
  • Mean testosterone concentration [ Time Frame: Measured at each treatment visit ] [ Designated as safety issue: No ]
  • "Acute-on-chronic" changes in testosterone and Luteinizing Hormone (LH) levels [ Time Frame: From just prior to the second (Week 24) injection through the visit 14 days post-second injection ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: March 2008
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Leuprolide acetate Formulation A
Drug: Leuprolide acetate formulation A
Two intramuscular injections of Formulation A 45 mg 6 month depot administered 24 weeks apart.
2: Experimental
Leuprolide acetate Formulation B
Drug: Leuprolide acetate formulation B
Two intramuscular injections of Formulation B 45 mg 6-month depot administered 24 weeks apart.

Detailed Description:

Subjects will receive a total of two intramuscular injections, administered 24 weeks apart.

Approximately 300 male subjects will be enrolled. The first 150 enrolled will receive Formulation A for both injections and the next 150 will receive Formulation B for both injections.

This study will be conducted by approximately 60-80 investigative sites. Patients will participate in the trial for approximately 14 months.

This trial includes a Screening Period (up to 4 weeks), 12-month Treatment Period (two 6 month treatment cycles), and a Follow-Up Period (30 days). This trial will include a total of 20 visits (Screening Visit, 18 Treatment Period Visits, and a Post-Treatment Follow-Up Visit).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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/dL 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/dL 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 ULN.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626431

  Show 58 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Peter Bacher, Global Project Head )
Study ID Numbers: L-PC07-169
Study First Received: February 20, 2008
Last Updated: September 30, 2009
ClinicalTrials.gov Identifier: NCT00626431     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Lupron Depot
prostate cancer

Additional relevant MeSH terms:
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009