title: Radical prostatectomy versus high-dose irradiation in localized/locally advanced prostate cancer: A Swedish multicenter randomized trial with patient-reported outcomes.
abstract: BACKGROUND
  Treatment of localized prostate cancer (PC) is controversial. This is the first randomized study comparing an open surgery procedure (radical prostatectomy) with a combination of high-dose rate brachytherapy (2×10 Gy) and external beam radiotherapy (25×2 Gy) in PC patients in Sweden 1996-2001. The two randomization arms were compared regarding differences in patients-reported outcomes, such as complications and health-related quality of life (HRQoL).
  
  
  METHODS
  The patients had localized/locally advanced PC, clinical category T1b-T3a, N0, M0 and PSA≤50 ng/ml. All underwent total androgen blockade (six months). Self-reported HRQoL and symptoms including urinary, bowel, and sexual side effects were investigated prospectively before randomization and 12 and 24 months after randomization. A total of 89 patients were randomized and completed the EORTC QLQ C-33 and EORTC PR-25 questionnaires.
  
  
  RESULTS
  Over the study period, there were no discernible differences in HRQoL, or complications between the two groups. Emotional functioning, however, improved statistically significantly over time, whereas Social functioning decreased, and financial difficulties increased. No statistically significant differences in group-by-time interactions were found. The survival rate was 76%. Only eight patients (9%) died of PC.
  
  
  CONCLUSIONS
  Open radical prostatectomy and the combined high-dose rate brachytherapy with external beam radiation appeared to be comparable in the measured outcomes. It was not possible to draw any conclusion on the efficacy of the two treatments due to insufficient power of the study.
authors.affiliation: Department of Oncology-Pathology, Karolinska Institutet , Stockholm , Sweden.
authors.forename: Bo
authors.initials: B
authors.lastname: Lennernäs
authors.forename: Khairul
authors.initials: K
authors.lastname: Majumder
authors.forename: Jan-Erik
authors.initials: JE
authors.lastname: Damber
authors.forename: Per
authors.initials: P
authors.lastname: Albertsson
authors.forename: Erik
authors.initials: E
authors.lastname: Holmberg
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Brandberg
authors.forename: Ulf
authors.initials: U
authors.lastname: Isacsson
authors.forename: Gunilla
authors.initials: G
authors.lastname: Ljung
authors.forename: Ole
authors.initials: O
authors.lastname: Damm
authors.forename: Sten
authors.initials: S
authors.lastname: Nilsson
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001918:Brachytherapy / Q000009:adverse effects; D017281:Cost of Illness; D004644:Emotions; D007172:Erectile Dysfunction / Q000209:etiology; D005242:Fecal Incontinence / Q000209:etiology; D005485:Flutamide / Q000008:administration & dosage; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011468:Prostatectomy / Q000009:adverse effects / Q000379:methods*; D011471:Prostatic Neoplasms / Q000473:pathology* / Q000628:therapy*; D011788:Quality of Life; D011879:Radiotherapy Dosage; D058992:Social Participation; D011795:Surveys and Questionnaires; D015996:Survival Rate; D013548:Sweden; D014549:Urinary Incontinence / Q000209:etiology
chemical_list: D005485:Flutamide; D016729:Leuprolide