A Randomised Controlled Trial to Determine the Effect of Triptorelin on Reduction of Prostate Volume PreRadiotherapy Compared with Standard Therapy (Goserelin)

Amit Bahl, Amarnath Challapalli, Rosemary Greenwood, Hannah Kirk, Krishna Garadi, Karen Bobruk, Rebecca Houlihan, Katy Tucker, Katrina Hurley, Salah Al Buheissi, Emma Gray and Raj Persad

Department of Clinical Oncology, University Hospitals Bristol NHS Foundation Trust, UK
Department of Research Design Service, University Hospitals Bristol NHS Foundation Trust, UK
Department of Research Unit, University Hospitals Bristol NHS Foundation Trust, UK
Department of Urology, Bristol Urological Institute, UK
Musgrove Park Hospital, Taunton, UK

^*Correspondance to: Amit Bahl 

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Abstract:

Objectives: To evaluate the non-inferiority of cytoreductive efficacy and effect on QoL of neoadjuvant Triptorelin as compared with Goserelin.Materials and
Methods: Seventy-one patients with localised CaP were randomised to receive either neoadjuvant Triptorelin (n=37) or Goserelin (n=34). Prostate volume was measured (Transrectal Ultrasound (TRUS)), at baseline and 14 weeks after start of therapy. PSA, testosterone and QoL questionnaires were completed at baseline, 6, 10 and 14 weeks after start of therapy. Changes in TRUS volume, QoL scores; analysed as mean scores over the 4 treatment time points, were evaluated using analysis of covariance, with baseline as covariate.Results: The mean (S.D.) reduction in prostate volume after 12 weeks of Goserelin and Triptorelin was 36.8% (18.3) and 30.7% (17.7), respectively (mean difference of prostate volume was 3.11 cc). Twenty-nine out of 34 in Goserelin group (85.0%) and 33/37 patients in Triptorelin group (89.0%) achieved castrate levels of testosterone. The median time-to-castration was 6.1 (95% CI: 5.8-6.5) and 6.4 (95% CI: 5.9-10.0) weeks for Goserelin and Triptorelin, respectively. There was no significant trend towards worsening QoL with either Goserelin or Triptorelin in the global (EQ5D), cancer-specific (QLQ-C30), and symptom scores in QLQ-PR25 questionnaire with the exception of hormone symptoms. The hormone symptoms showed an increasing trend over 4 treatment time points, with those in the Goserelin arm more affected (p=0.02) than patients in the Triptorelin arm, despite non-inferiority in cytoreductive effect.Conclusion: To our knowledge this is the first reported prospective randomised data demonstrating the non-inferiority of Triptorelin in terms of cytoreductive efficacy and QoL scores in the neoadjuvant setting, as compared to Goserelin. Further validation, within a larger sample size is required to evaluate impact of hormone symptoms.

Keywords:

Goserelin; Triptorelin; Cyto-reduction; Quality of Life; Neoadjuvant; Radiotherapy; Non-inferiority

Cite the Article:

Bahl A, Challapalli A, Greenwood R, Kirk H, Garadi K, Bobruk K, et al. A Randomised Controlled Trial to Determine the Effect of Triptorelin on Reduction of Prostate Volume PreRadiotherapy Compared with Standard Therapy (Goserelin). Clin Oncol. 2019; 4: 1598.