Two negatives don’t make a positive in patients with CRPC

Data from a small Phase II trial of cilengitide suggest that it  has minimal clinical effect in the treatment of men with non-metastatic, castration-resistant prostate cancer (CRPC). They also suggest that levels of circulating T-cells (CTCs) are of limited utility in monitoring the progression of this patient group.

Cilengitide (also known as EMD 121974) is a selective integrin antagonist that was tested by Alva et al. for its clinical effect on men with non-metastatic CRPC. The trial was coordinated by the Prostate Cancer Clinical Trials Consortium with support from the Department of Defense’s Prostate Cancer Research Program.

Data from this study showed that:

  • 13/16 patients enrolled were actually eligible for study participation.
  • The patients had an average (median) age of 65.5 years, a baseline PSA 8.4 of ng/ml, and a median Gleason score of 7.
  • Patients were treated with 2,000 mg cilengitide given intravenously, twice weekly, until toxicity/progression.
  • A median of three cycles of cilengitide was administered.
  • Cilengitide appears to have been well tolerated, with just two cases of Grade 3 toxicity and no Grade 4 toxicities.
  • There were no PSA responses, however, and 11/13 patients progressed by PSA after three cycles of treatment.
  • The median time to disease progression was 1.8 months.
  • Baseline CTCs were detected in just  1/9 patients.
  • CTC levels had increased (from 0 to 1) in 2 patients, remained at 0 in 2 patients), or decreased (from 23 to 0) in 1 patient at progression.


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