Quality of life evaluation of the effect of decapeptyl compared with zoladex preradiotherapy: Final results of randomised controlled trial.

Abstract

62 Background: Hormone therapy in combination with radiotherapy is a curative treatment option for prostate cancer (CaP). There is paucity of data regarding quality of life (QoL) evaluation of neoadjuvant Decapeptyl. We reported on the equivalence of cytoreductive efficacy of neoadjuvant Decapeptyl and Zoladex previously. Here we present the final QoL evaluation of the effect of Decapeptyl compared with Zoladex preradiotherapy. Methods: Seventy-one patients with localised CaP who have chosen radical radiotherapy had been randomised by stratified block design, toreceive either Decapeptyl (D: n = 37) or Zoladex (Z: n = 34) with bicalutamide cover. All the patients had subsequent radical radiotherapy and followed up as per departmental protocol. The effect of Decapeptyl and Zoladex on QoL was assessed using EQ5D, QLQ-PR25, QLQ-C30 questionnaires, which were completed at baseline, 6, 10 & 14 weeks after start of therapy. QoL scores were analysed as mean scores over the 4 treatment time points for all domains, controlling for baseline scores using Analysis of Covariance. Results: There was no clinically significant difference or trend towards worsening QoL with either Z or D in the global (EQ5D) and cancer-specific (QLQ-C30) domains. The cancer-specific (QLQ-C30) symptom score also showed no trend towards worsening QoL with either Z or D. Symptom scores in the QLQ-PR25 questionnaire did not show a significant difference between Z and D arms with the exception of hormone symptoms. The hormone symptoms showed an increasing trend over the 4 treatment time points, with those in the Z arm significantly (p = 0.02) more affected (3 points higher on average) than patients in the D arm, despite equivalence in cytoreductive effect and achieving castrate levels of testosterone. Conclusions: There were no clinically significant differences in QoL domains between Zoladex and Decapeptyl, apart from hormones symptoms which were worse with Zoladex. Further validation is required with affect on hormone symptoms as the primary outcome measure. To our knowledge this is the first reported prospective randomised data demonstrating the effect of Zoladex and Decapeptyl, on QoL in the neoadjuvant setting. Clinical trial information: EduraCT: 2008-007028-25.