title: Higher sexual interest with androgen receptor inhibitor monotherapy than with castration plus an androgen receptor inhibitor in prostate cancer patients treated with curative radiotherapy, but otherwise small health-related quality of life differences: A randomised prospective 18-month follow-up study.
abstract: To prospectively study differences in health-related quality of life (HRQoL) in patients with localised/locally advanced prostate cancer (PC) treated with curative intended radiation therapy and randomised to androgen receptor inhibitor monotherapy treatment versus castration plus an androgen receptor inhibitor used continuously. Time to Prostate Specific Antigen (PSA) relapse, time to symptomatic metastasis and overall survival (OS) were also described for the two groups.
  
  
  
  From 2005 to 2011, a total of 110 patients were randomised at a ratio of 1:1. HRQoL was assessed at six time points: before randomisation, before radiotherapy (RT) start and 9, 12, 15 and 18 months after randomisation, using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC QLQ-PR25.
  
  
  
  At the 3-month follow-up, statistically significant differences between the two groups were found for overall quality of life (p = 0.006), fatigue (p = 0.023), sexual interest (p < 0.001) and urinary problems (p = 0.036). Small clinical differences were noted for overall quality of life, role functioning, fatigue, pain, sleeping problems and urinary problems. At that assessment point, clinical differences between the groups were substantial regarding sexual interest and moderate regarding sexual functioning (the latter indicated only by patients reporting having sexual interest at baseline). All statistical and clinical differences favoured the androgen receptor inhibitor monotherapy arm. At 18 months after randomisation, statistically significant differences were found for cognitive functioning (p = 0.040) and sexual interest (p = 0.011), both favouring the androgen receptor inhibitor monotherapy arm.
  
  
  
  The results suggest that neo-adjuvant androgen receptor inhibitor monotherapy might be preferred compared to castration plus an androgen receptor inhibitor before curative intended RT in men with localised/locally advanced PC, with higher levels of HRQoL, especially concerning sexual interest. HRQoL differences over time were small. The observation time and study sample were too small for evaluating time to PSA progression and OS. Further studies are needed to confirm the results. The study was registered in, identification number NCT02382094.
authors.affiliation: Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden; Department of Oncology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: khairul.majumder@karolinska.se.
authors.forename: Khairul
authors.initials: K
authors.lastname: Majumder
authors.affiliation: Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Sten
authors.initials: S
authors.lastname: Nilsson
authors.affiliation: Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Hemming
authors.initials: H
authors.lastname: Johansson
authors.affiliation: Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden; Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Ullén
authors.affiliation: Department of Oncology, University Hospital Örebro, Örebro, Sweden.
authors.forename: Bo
authors.initials: B
authors.lastname: Lennernäs
authors.affiliation: Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden; Center for Digestive Diseases, Department of Gastro-centrum, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Mia
authors.initials: M
authors.lastname: Bergenmar
authors.affiliation: Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Brandberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods / Q000523:psychology; D005500:Follow-Up Studies; D006801:Humans; D007989:Libido; D008297:Male; D008875:Middle Aged; D009919:Orchiectomy; D057240:Patient Preference; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology / Q000628:therapy*; D011788:Quality of Life; D011878:Radiotherapy / Q000379:methods; D012725:Sexual Behavior / Q000187:drug effects
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D017430:Prostate-Specific Antigen
keywords: Anti-androgen; Prostate cancer; Radiation therapy; Sexual function