• Medientyp: E-Artikel
  • Titel: Employing the treatment‐free interval of intermittent androgen ablation to screen candidate prostate cancer therapies
  • Beteiligte: Mao, Shifeng; Daliani, Danai D.; Wang, Xuemei; Thall, Peter F.; Do, Kim‐Anh; Perez, Cherie A.; Brown, Melissa A.; Bouchillon, Kathleen; Carter, Cindy M.; Logothetis, Christopher J.; Kim, Jeri
  • Erschienen: Wiley, 2007
  • Erschienen in: The Prostate
  • Sprache: Englisch
  • DOI: 10.1002/pros.20649
  • ISSN: 0270-4137; 1097-0045
  • Schlagwörter: Urology ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec><jats:title>BACKGROUND</jats:title><jats:p>Because neither continuous nor intermittent hormonal therapy is curative, we designed a clinical model to screen new drugs for additive or synergistic effects with hormonal therapy and used IM862, a naturally occurring dipeptide with antiangiogenic and immunomodulatory properties, to test it.</jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p>Patients with prostate cancer who had rising PSA levels after radical prostatectomy and/or radiation therapy were given combined androgen ablation for 3 months. After 2 months' treatment, patients were randomly assigned in a double‐blind fashion to receive intranasal IM862 or placebo daily. Treatment continued for 6 months or until disease progression, which was defined by a rising serum PSA level, the appearance of new skeletal or extraskeletal metastatic disease, or new symptoms requiring intervention.</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>Seventy‐one patients were evaluable for response. Median time to PSA progression was not reached in either group. At 6 months, disease had progressed in 14 (41%) of the 34 patients receiving treatment and 18 (49%) of the 37 receiving placebo (<jats:italic>P</jats:italic> = 0.39). No significant toxicities emerged.</jats:p></jats:sec><jats:sec><jats:title>CONCLUSIONS</jats:title><jats:p>The model was demonstrated to be an efficient platform for new drug screening; however, IM862, though well tolerated, failed to demonstrate superiority over placebo in prolonging time to PSA progression. Prostate 67: 1677–1685, 2007. © 2007 Wiley‐Liss, Inc.</jats:p></jats:sec>