title: Ten- and 15-yr Prostate Cancer-specific Mortality in Patients with Nonmetastatic Locally Advanced or Aggressive Intermediate Prostate Cancer, Randomized to Lifelong Endocrine Treatment Alone or Combined with Radiotherapy: Final Results of The Scandinavian Prostate Cancer Group-7.
abstract: In high-risk prostate cancer (PCa), no study with observation times beyond 10 yr has demonstrated survival improvement after addition of prostatic radiotherapy (RAD) to endocrine treatment (ET) alone.
  
  
  
  To compare mortality rates in patients receiving ET alone versus ET + RAD.
  
  
  
  From 1996 to 2002, 875 Scandinavian patients with high-risk (90%) or intermediate PCa were randomized to ET or ET + RAD (The Scandinavian Prostate Cancer Group-7). After 3 mo with total androgen blockade in all patients, all individuals continued lifelong antiandrogen monotherapy. Those randomized to ET + RAD started prostate radiotherapy (70Gy) at 3 mo.
  
  
  
  PCa-specific 15-yr mortality represented the primary endpoint. Assessment of the combination treatment effect and prognostic factors was performed in competing risk analyses and Cox proportional-hazard models.
  
  
  
  RAD added to ET.
  
  
  
  With a median observation time of 12 yr, the 15-yr PCa-specific mortality rates were 34% (95% confidence interval, 29-39%) and 17% (95% confidence interval, 13-22%) in the ET and ET + RAD arms respectively (p<0.001). Compared with the ET arm, the median overall survival in the ET + RAD arm was prolonged by 2.4 yr. Treatment with ET alone, age ≥65 yr and increasing histology grade independently increased the risk of PCa-specific and overall mortality. Limitations include nonformal evaluation of comorbidity, the inability to calculate progression-free survival, and lack of information about salvage therapy and toxicity.
  
  
  
  In patients with nonmetastatic locally advanced or aggressive PCa, ET + RAD reduces the absolute risk of PCa-specific death by 17% at 15 yr compared with ET alone; the comparable 15-yr PCa-specific mortality rates being 17% and 34%. The results warrant a phase 3 study comparing ET + RAD with radical prostatectomy in high-risk PCa.
  
  
  
  Adding prostatic therapy to lifelong antiandrogen therapy halves the absolute risk of death from prostate cancer from 34% to 17% 15 yr after diagnosis.
authors.affiliation: Oslo University Hospital, National Advisory Unit on Late Effects after Cancer Treatment, Oslo University Hospital, Oslo, Norway; Cancer Registry of Norway, University of Oslo, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: sdf@ous-hf.no.
authors.forename: Sophie D
authors.initials: SD
authors.lastname: Fosså
authors.affiliation: Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.
authors.forename: Fredrik
authors.initials: F
authors.lastname: Wiklund
authors.affiliation: Department of Oncology, Ålesund Hospital, Ålesund, Norway.
authors.forename: Olbjørn
authors.initials: O
authors.lastname: Klepp
authors.affiliation: Urology Clinical Center, Trondheim, Norway.
authors.forename: Anders
authors.initials: A
authors.lastname: Angelsen
authors.affiliation: The Cancer Clinic, St. Olavs University Hospital, Trondheim, Norway.
authors.forename: Arne
authors.initials: A
authors.lastname: Solberg
authors.affiliation: Department of Urology, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg. Gothenburg, Sweden.
authors.forename: Jan-Erik
authors.initials: JE
authors.lastname: Damber
authors.affiliation: Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Morten
authors.initials: M
authors.lastname: Hoyer
authors.affiliation: Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Widmark
mesh_terms: D000368:Aged; D059002:Androgen Receptor Antagonists / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005485:Flutamide / Q000008:administration & dosage; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011471:Prostatic Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D011878:Radiotherapy; D012307:Risk Factors; D012537:Scandinavian and Nordic Countries; D015996:Survival Rate; D013997:Time Factors
chemical_list: D059002:Androgen Receptor Antagonists; D018931:Antineoplastic Agents, Hormonal; D007987:Gonadotropin-Releasing Hormone; D005485:Flutamide
keywords: Antiandrogen monotherapy; High-risk prostate cancer; Mortality; Radiotherapy