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

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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.

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Acknowledgements

Bayer Pharma AG (former Schering AG) Berlin supported the trial. There was no role in the study design; in the collection, analysis and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.

Conflict of interest

None of the authors has a conflict of interest.

Author information

Authors and Affiliations

  1. Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands

    Paul C. M. S. Verhagen, Mark F. Wildhagen, Annet M. Verkerk, Chris H. Bangma & Fritz H. Schröder

  2. P. Stradins University Hospital, Riga, Latvia

    Egils Vjaters

  3. North-Estonia Regional Hospital, Tallinn, Estonia

    Hembo Pagi & Leonhard Kukk

  4. General Hospital Maribor, Maribor, Slovenia

    Dejan Bratus

  5. Urologicka klinika FN, Olomouc, Czech Republic

    Richard Fiala

  6. Department of Urology, Causeway Hospital, 4 Newbridge Road, Coleraine, BT521HS, UK

    Richard Fiala

  7. Centrum für Operative Urologie Bremen, Bremen, Germany

    Gerald H. J. Mickisch

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  1. Paul C. M. S. Verhagen
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  2. Mark F. Wildhagen
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  4. Egils Vjaters
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  6. Leonhard Kukk
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  7. Dejan Bratus
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  8. Richard Fiala
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  9. Chris H. Bangma
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  10. Fritz H. Schröder
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  11. Gerald H. J. Mickisch
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Corresponding author

Correspondence to Paul C. M. S. Verhagen.

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345_2013_1206_MOESM1_ESM.docx

Figure 4 Kaplan Meier curves showing results for continuous and intermittent treatment. a) time to overall progression in phase 1; b) cancer-specific survival; c) overall survival. (no significant differences). (DOCX 69 kb)

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Verhagen, P.C.M.S., Wildhagen, M.F., Verkerk, A.M. et al. Intermittent versus continuous cyproterone acetate in bone metastatic prostate cancer: results of a randomized trial. World J Urol 32, 1287–1294 (2014). https://doi.org/10.1007/s00345-013-1206-0

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  • DOI: https://doi.org/10.1007/s00345-013-1206-0

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