# ProtecT: 10-year outcomes after monitoring, surgery or radiotherapy for localised prostate cancer

Source: https://onco.cc/key-papers/paper-protect-nejm-2016/  
OnCo record `paper-protect-nejm-2016` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In the only randomised trial to compare active monitoring, surgery and radiotherapy for PSA-detected localised prostate cancer, deaths from prostate cancer were rare and equal at ten years in all three groups, though monitoring led to more metastases and progression.

## Summary

Phase 3 trial of 1,643 men with PSA-detected localised prostate cancer randomised to active monitoring, radical prostatectomy or radiotherapy with six months of androgen deprivation.

Prostate cancer-specific mortality at ten years was about 1 percent in every group (17 deaths in total), while metastases (6.3 versus 2.4 and 3.0 per 1,000 person-years) and clinical progression were more frequent with monitoring; patient-reported outcomes showed distinct side-effect patterns for each treatment.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2016
- DOI: 10.1056/NEJMoa1606220
- Authors: Hamdy FC, Donovan JL, Lane JA, et al.
- Findings: Prostate cancer-specific mortality about 1 percent at ten years in all groups.; Metastases 6.3 per 1,000 person-years with monitoring vs 2.4 (surgery) and 3.0 (radiotherapy).
- What it means: Most men with low- and favourable intermediate-risk prostate cancer can safely choose monitoring, and treatment choice should weigh urinary, sexual and bowel side effects against a small difference in progression.
- Caveats: Most men had low-risk disease; about 20 percent were intermediate or high risk.; Active monitoring was less intensive than modern active surveillance with MRI.

## Sources

- N Engl J Med 2016: https://doi.org/10.1056/NEJMoa1606220
- PubMed: https://pubmed.ncbi.nlm.nih.gov/27626136/

## Connected records

- cancers: [Localised prostate cancer, intermediate risk](https://onco.cc/cancers/prostate-intermediate-risk/), [Localised prostate cancer, very low and low risk](https://onco.cc/cancers/prostate-low-risk/)
- trials: [ProtecT](https://onco.cc/trials/protect/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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