title: A phase II trial of imatinib mesylate in patients with biochemical relapse of prostate cancer after definitive local therapy.
abstract: OBJECTIVE
  To determine the biological effects of imatinib mesylate (STI-571, Gleevec; Novartis Pharmaceuticals, Inc., East Hanover, NJ, USA), as measured by prostate-specific antigen (PSA) kinetics in men with biochemical relapse of prostate cancer after definitive local therapy.
  
  
  METHODS
  Men with prostate cancer, who had had definitive local therapy, with nonmetastatic recurrent disease as manifested by a rising PSA level, were enrolled on this phase II trial. Men received 400 mg of imatinib mesylate orally twice daily and continuously until disease progression or unacceptable toxicity. The PSA level was measured monthly.
  
  
  RESULTS
  In all, 20 men with biochemically relapsed prostate cancer were treated. The median pretreatment PSA level was 5.4 ng/mL. Of the 19 evaluable men, one achieved a >or= 50% reduction in PSA level and two had decreases of <50%. For the 16 men in whom the on-treatment PSA doubling time (PSADT) could be calculated (those with increasing PSA level) the median PSADT did not increase significantly (5.8 vs 7.2 months, P = 0.64). Eleven of 20 men discontinued therapy due to toxicity and the trial was stopped early due to toxicity.
  
  
  CONCLUSIONS
  Based on the lack of PSA modulation and pronounced toxicities leading to early closure of this trial, further study of single-agent imatinib mesylate at this dose (400 mg twice daily) cannot be recommended in this patient population.
authors.affiliation: University of California/San Francisco, San Francisco, CA 94115, USA.
authors.forename: Amy M
authors.initials: AM
authors.lastname: Lin
authors.forename: Brian I
authors.initials: BI
authors.lastname: Rini
authors.forename: Vivian
authors.initials: V
authors.lastname: Weinberg
authors.forename: Kristen
authors.initials: K
authors.lastname: Fong
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Ryan
authors.forename: Jonathan E
authors.initials: JE
authors.lastname: Rosenberg
authors.forename: Lawrence
authors.initials: L
authors.lastname: Fong
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Small
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001549:Benzamides; D006801:Humans; D000068877:Imatinib Mesylate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000188:drug therapy*; D010879:Piperazines / Q000009:adverse effects*; D017430:Prostate-Specific Antigen / Q000097:blood / Q000187:drug effects*; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D011743:Pyrimidines / Q000009:adverse effects*; D017211:Treatment Failure
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate; D017430:Prostate-Specific Antigen