Intermittent versus continuous cyproterone acetate in bone metastatic prostate cancer: results of a randomized trial

Paul C.M.S. Verhagen, Mark F. Wildhagen, Annet M. Verkerk, Egils Vjaters, Hembo Pagi, Leonhard Kukk, Dejan Bratus, Richard Fiala, Chris H. Bangma, Fritz H. Schröder, Gerald H.J. Mickisch

Research output: Contribution to journalArticlepeer-review

17 Citations (Scopus)

Abstract

Background: To compare intermittent treatment (IT) versus continuous treatment (CT) using cyproterone acetate (CPA) in bone metastatic prostate cancer patients, we conducted an open-label, multicenter randomized trial. Continuous androgen deprivation therapy is the standard treatment in metastatic prostate cancer. Intermittent treatment might maintain efficacy while toxicity and costs are reduced.

Methods: Patients received CPA 100 mg tid in the prephase. Patients with a PSA decline of ≥90 % or PSA <4 ng/ml were randomized. If patients were progressive, LHRH analogues were added. Primary end point was time to PSA progression.

Results: A total of 366 patients were recruited; 258 reached a good response after 3 or 6 months and were randomized. A total of 131 patients randomized to IT and 127 to CT. Patients on IT had an average of 1.7 episodes on CPA, before LHRH analogues were started. The mean time without treatment in IT was 463 days versus 422 days on treatment. There were statistical significant differences between IT and CT in 3 of the 5 functional scales of EORTC QLQ C 30; however, the clinical relevance of this finding appears modest. Symptom and potency scales showed significant advantages for IT. There were no differences in time to PSA progression on CPA, time to PSA and/or clinical progression on LHRH analogues and time to cancer-specific and overall survival.

Conclusions: IT by CPA is associated with less symptoms and modest advantages in QOL domains. There were no differences in time to PSA progression, clinical progression or survival.

Original languageEnglish
Pages (from-to)1287-1294
Number of pages8
JournalWorld Journal of Urology
Volume32
Issue number5
DOIs
Publication statusPublished - Oct 2014
Externally publishedYes

Keywords

  • Androgen deprivation therapy (ADT)
  • Cyproterone acetate (CPA)
  • Intermittent ADT
  • Metastatic prostate cancer

Field of Science

  • 3.2 Clinical medicine

Publication Type

  • 1.1. Scientific article indexed in Web of Science and/or Scopus database

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