The Journal of Urology
Volume 175, Issue 2 , Pages 533-536 , February 2006

A 12-Month Clinical Study of LA-2585 (45.0 MG): A New 6-Month Subcutaneous Delivery System for Leuprolide Acetate for the Treatment of Prostate Cancer

  • E. David Crawford

      Affiliations

    • University of Colorado Health Sciences Center, Fort Collins, Colorado
    • Corresponding Author InformationCorrespondence: Section of Urologic Oncology, University of Colorado Health Sciences Center, P. O. Box 6510, Mail Stop F-710, Aurora, Colorado 80045 (telephone: 720-848-0195; FAX: 720-848-0203)
    • Financial interest and/or other relationship with Merck, Sanofi-Aventis, Celgene, Andrx/Auxilium, National Institutes of Health, University of Colorado Cancer Center, Oncura and Praecus.
  • ,
  • Oliver Sartor

      Affiliations

    • Louisiana State University, New Orleans, Louisiana
    • Financial interest and/or other relationship with Atrix Laboratories and Sanofi-Aventis.
  • ,
  • Franklin Chu

      Affiliations

    • San Bernardino Urological Associates, San Bernardino, California
  • ,
  • Ramon Perez

      Affiliations

    • Urology Health Center, New Port Richey, Florida
    • Financial interest and/or other relationship with Atrix Laboratories and Sanofi-Aventis.
  • ,
  • Gary Karlin

      Affiliations

    • Lawrenceville Urology, Lawrenceville, New Jersey
    • Financial interest and/or other relationship with Atrix Laboratories.
  • ,
  • J. Steve Garrett

      Affiliations

    • Aurora and Atrix Laboratories, Inc., Fort Collins, Colorado
    • Financial interest and/or other relationship with QLT USA.

Received 8 March 2005

References 

  1. Sharifi R , Bruskewitz RC , Gittleman MC , Graham SD , Hudson PB , Stein B . Leuprolide acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer . Clin Ther . 1996;18:647
  2. Millikan R , Logothetis C . Update of the NCCN guidelines for treatment of prostate cancer . Oncology (Williston Park) . 1997;11:180
  3. Bahnson RR , Hanks GE , Huben RP , Kantoff P , Kozlowski JM , Kuettel M , et al.   NCCN Practice Guidelines for Prostate Cancer . Oncology (Williston Park) . 2000;14:111
  4. Tunn UW , Bargelloni U , Cosciani S , Fiaccavento G , Guazzieri S , Pagano F . Comparison of LH-RH analogue 1-month depot and 3-month depot by their hormone levels and pharmacokinetic profile in patients with advanced prostate cancer . Urol Int . 1998;60(suppl):9
  5. Sharifi R , Knoll LD , Smith J , Kramolowsky E . Leuprolide acetate (30-mg depot every four months) in the treatment of advanced prostate cancer . Urology . 1998;51:271
  6. Fowler JE , Gottesman JE , Reid CF , Andriole GL , Soloway MS . Safety and efficacy of an implantable leuprolide delivery system in patients with advanced prostate cancer . J Urol . 2000;164:730
  7. Perez-Marreno R , Chu FM , Gleason D , Loizides E , Wachs B , Tyler RC . A six-month, open-label study assessing a new formulation of leuprolide 7.5 mg for suppression of testosterone in patients with prostate cancer . Clin Ther . 2002;24:1902
  8. Oefelein MG , Cornum R . Failure to achieve castrate levels of testosterone during luteinizing hormone releasing hormone agonist therapythe case for monitoring serum testosterone and a treatment decision algorithm . J Urol . 2000;164:726
  9. Ravivarapu HB , Moyer KL , Dunn RL . Parameters affecting the efficacy of a sustained release polymeric implant of leuprolide . Int J Pharmacol . 2000;194:181
  10. Davidson JS , Wakefield IK , Millar RP . Absence of rapid desensitization of the mouse gonadotropin-releasing hormone receptor . Biochem J . 1994;300:299
  11. Messing EM , Manola J , Sarosdy M , Wilding G , Crawford ED , Trump D . Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer . New Engl J Med . 1999;341:1781

 Study informed consent received institutional review board approval.

PII: S0022-5347(05)00161-8

doi: 10.1016/S0022-5347(05)00161-8

The Journal of Urology
Volume 175, Issue 2 , Pages 533-536 , February 2006