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Prostate Cancer

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

By: Sophie D. Fossåa b c , Fredrik Wiklundd, Olbjørn Kleppe, Anders Angelsenf, Arne Solbergg, Jan-Erik Damberh, Morten Hoyeri and Anders Widmarkj on behalf of the The Scandinavian Prostate Cancer Group-7 Investigators.

European Urology, Volume 70 Issue 4, October 2016, Pages 684-691

Published online: 01 October 2016

Keywords: Antiandrogen monotherapy, High-risk prostate cancer, Radiotherapy, Mortality

Abstract Full Text Full Text PDF (342 KB)

Abstract

Background

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.

Objective

To compare mortality rates in patients receiving ET alone versus ET + RAD.

Design, settings, and participants

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 (70 Gy) at 3 mo.

Outcome, measurements and statistical analysis

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.

Intervention

RAD added to ET.

Results and limitations

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.

Conclusions

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.

Patient summary

Adding prostatic therapy to lifelong antiandrogen therapy halves the absolute risk of death from prostate cancer from 34% to 17% 15 yr after diagnosis.

Take Home Message

In high-risk prostate cancer, radiotherapy (70 Gy) added to life-long oral antiandrogen monotherapy results in 91% cause-specific survival compared with 81% after antiandrogens alone. The results after combined treatment are similar to those after radical prostatectomy.

Keywords: Antiandrogen monotherapy, High-risk prostate cancer, Radiotherapy, Mortality.

Footnotes

a Oslo University Hospital, National Advisory Unit on Late Effects after Cancer Treatment, Oslo University Hospital, Oslo, Norway

b Cancer Registry of Norway, University of Oslo, Oslo, Norway

c Faculty of Medicine, University of Oslo, Oslo, Norway

d Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden

e Department of Oncology, Ålesund Hospital, Ålesund, Norway

f Urology Clinical Center, Trondheim, Norway

g The Cancer Clinic, St. Olavs University Hospital, Trondheim, Norway

h Department of Urology, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg. Gothenburg, Sweden

i Department of Oncology, Aarhus University Hospital, Aarhus, Denmark

j Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden

Corresponding author. Oslo University Hospital, Radiumhospitalet, Postboks 4953 Nydalen, Oslo 0424, Norway. Tel. +47 22934700; Fax: +47 22934553.

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