A Study of Leuprolide to Treat Prostate Cancer

NCT ID: NCT00626431

Last Updated: 2011-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-09-30

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 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.

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, administered 24 weeks apart. The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects were to receive Formulation B for both injections. The sponsor was to conduct an ongoing review of the primary endpoint data (suppression of testosterone <= 50 ng/dL) and planned to stop enrollment of Formulation A or Formulation B, or not to administer the second injection of Formulation A or Formulation B, if 15 or more subjects did not achieve testosterone suppression by Week 4 or failed to maintain testosterone suppression during the treatment period.

All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B.

This study was to be conducted at approximately 60-80 investigative sites. Subjects participated in the trial for approximately 14 months.

This trial was to include a Screening Period (up to 4 weeks), a 12-month Treatment Period (two 6-month treatment cycles), and a Follow-Up Period (30 days).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leuprolide acetate - Formulation A

Leuprolide acetate 45 mg, 6-month depot

Group Type: EXPERIMENTAL

Leuprolide acetate - Formulation A

Intervention Type: DRUG

Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart.

Leuprolide acetate - Formulation B

Leuprolide acetate, 45 mg, 6-month depot

Group Type: EXPERIMENTAL

Leuprolide acetate - Formulation B

Intervention Type: DRUG

Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.

Interventions

Leuprolide acetate - Formulation A

Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart.

Intervention Type: DRUG

Leuprolide acetate - Formulation B

Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.

Intervention Type: DRUG

Other Intervention Names

Lupron; leuprorelin; gonadotropin hormone-releasing hormone (GnRH); luteinizing hormone-releasing hormone (LHRH); Lupron; leuprorelin; gonadotropin hormone-releasing hormone (GnRH); luteinizing hormone-releasing hormone (LHRH)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Kristof Chwalisz, MD, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 8696

Birmingham, Alabama, United States

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# 8661

St. Petersburg, Florida, United States

Site Reference ID/Investigator# 8568

Tallahassee, Florida, United States

Site Reference ID/Investigator# 8679

Wellington, Florida, United States

Site Reference ID/Investigator# 8562

West Palm Beach, Florida, United States

Site Reference ID/Investigator# 8670

Roswell, Georgia, United States

Site Reference ID/Investigator# 9708

Thomasville, Georgia, United States

Site Reference ID/Investigator# 8693

Fort Wayne, Indiana, United States

Site Reference ID/Investigator# 8690

Newburgh, Indiana, United States

Site Reference ID/Investigator# 8565

Overland Park, Kansas, United States

Site Reference ID/Investigator# 8676

Greenbelt, Maryland, United States

Site Reference ID/Investigator# 8653

Las Vegas, Nevada, United States

Site Reference ID/Investigator# 8667

Lawrenceville, New Jersey, United States

Site Reference ID/Investigator# 8665

New York, New York, United States

Site Reference ID/Investigator# 8657

Poughkeepsie, New York, United States

Site Reference ID/Investigator# 9702

The Bronx, New York, United States

Site Reference ID/Investigator# 8680

Charlotte, North Carolina, United States

Site Reference ID/Investigator# 8673

Concord, North Carolina, United States

Site Reference ID/Investigator# 8666

Raleigh, North Carolina, United States

Site Reference ID/Investigator# 8570

Salisbury, North Carolina, United States

Site Reference ID/Investigator# 8644

Winston-Salem, North Carolina, United States

Site Reference ID/Investigator# 8663

Cincinnati, Ohio, United States

Site Reference ID/Investigator# 8567

Columbus, Ohio, United States

Site Reference ID/Investigator# 8678

Bethany, Oklahoma, United States

Site Reference ID/Investigator# 8563

Bala-Cynwyd, Pennsylvania, United States

Site Reference ID/Investigator# 8692

Lancaster, Pennsylvania, United States

Site Reference ID/Investigator# 8689

Myrtle Beach, South Carolina, United States

Site Reference ID/Investigator# 8643

Germantown, Tennessee, United States

Site Reference ID/Investigator# 8695

Germantown, Tennessee, United States

Site Reference ID/Investigator# 8685

Memphis, Tennessee, United States

Site Reference ID/Investigator# 8564

Nashville, Tennessee, United States

Site Reference ID/Investigator# 8645

Nashville, Tennessee, United States

Site Reference ID/Investigator# 8641

Dallas, Texas, United States

Site Reference ID/Investigator# 8675

Houston, Texas, United States

Site Reference ID/Investigator# 8684

San Antonio, Texas, United States

Site Reference ID/Investigator# 8649

Tyler, Texas, United States

Site Reference ID/Investigator# 8683

Salt Lake City, Utah, United States

Site Reference ID/Investigator# 8672

Norfolk, Virginia, United States

Site Reference ID/Investigator# 8669

Richmond, Virginia, United States

Countries

United States

References

Spitz A, Young JM, Larsen L, Mattia-Goldberg C, Donnelly J, Chwalisz K. Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer. Prostate Cancer Prostatic Dis. 2012 Mar;15(1):93-9. doi: 10.1038/pcan.2011.50. Epub 2011 Oct 25.

Reference Type: DERIVED

PMID: 22025196 (View on PubMed)

Other Identifiers

L-PC07-169

Identifier Type: -

Identifier Source: org_study_id