10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer

4 min


The management of clinically localised prostate cancer diagnosed after a PSA test remains controversial. Active surveillance (here called ‘active monitoring’) is an option that can help ameliorate the negative effects of over-treatment of PSA-detected prostate cancer.

The longer term outcomes of this approach compared to active treatment after diagnosis (surgery and/or radiotherapy) are still uncertain, with concerns about worse outcomes for men undergoing active surveillance.


This UK trial (ProtecT) compared active monitoring, radical prostatectomy and external beam radiotherapy with respect to prostate-cancer mortality at a median of 10 years of follow-up.

Groups were also compared for rates of disease progression, metastases, and all-cause mortality.


Between 1999 and 2009, 82,429 men aged between 50 and 69 years received a PSA test. From these, 2664 were diagnosed with localised prostate cancer.

Treatment options were discussed with the men and 62% of those diagnosed (n=1643) agreed to be randomised to one of 3 treatment options: 545 to the active monitoring arm, 553 to the surgery arm and 545 to radiotherapy.

After randomisation, clinicians and patients were aware of the treatment assignment.

Those in the active monitoring arm were regularly monitored for PSA level (every 3 months in the 1st year, 6-monthly in the 2nd year and yearly thereafter) to detect disease progression; active treatment with curative intent was implemented as necessary.

The primary outcome was prostate-cancer mortality (deaths definitely or probably due to prostate cancer or its treatment) at a median of 10 years follow-up.

Secondary outcomes included the rates of disease progression, metastases, and all-cause mortality. Statistical analysis was done on an intention-to-treat basis with Cox proportional hazards regression.


Fourteen (1%) of the 1643 randomised men were lost to follow-up for secondary outcomes but the primary outcome was ascertained for all participants.

88% of the active monitoring group, 71% of the surgery group and 74% of the radiotherapy group received treatment within 9 months of randomisation (>85% of the latter 2 groups received treatment by the end of the follow-up period).

Of the 545 men in the active monitoring group, 55% had received active treatment by the end of the follow-up. Of the men in the radiotherapy group, 3 had salvage prostatectomy, 14 received long-term ADT and 1 high-intensity focused U/S therapy.

Of the surgical group, 18 had primary treatment failure (5 had salvage radiotherapy) and another 9 men had adjuvant radiotherapy within a year of surgery.

Prostate-cancer-specific survival was 99% and did not differ significantly between groups.

There were 17 prostate-cancer-specific deaths overall: 8 in the active-monitoring group (1.5/1000 person-years (PY); 95% CI: 0.7 to 3.0), 5 in the surgery group (0.9/1000 PY; 95% CI: 0.4 to 2.2), and 4 in the radiotherapy group (0.7/1000 PY; 95% CI: 0.3 to 2.0); the difference across groups was not significant (P=0.48 for the overall comparison).

No significant difference was seen across the groups for all-cause mortality (169 deaths; P=0.87 for the comparison across three groups).

Metastases developed in more men in the active-monitoring group (33 men; 6.3/1000 PY; 95% CI: 4.5 to 8.8) than in the surgery group (13 men; 2.4/1000 PY; 95% CI, 1.4 to 4.2) or the radiotherapy group (16 men; 3.0/1000 PY; 95% CI: 1.9 to 4.9) (P=0.004 for the overall comparison).

Higher rates of disease progression were seen in the active-monitoring group (112 men; 22.9/1000 PY; 95% CI: 19.0 to 27.5) than in the surgery group (46 men; 8.9/1000 PY; 95% CI: 6.7 to 11.9) or the radiotherapy group (46 men; 9.0/1000 PY; 95% CI: 6.7 to 12.0) (P


At a median follow-up of 10 years, prostate-cancer-specific mortality was low irrespective of the treatment assigned, with no significant difference among treatments.

This mortality rate was lower than expected at the beginning of the trial. Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring.

However, nearly half the men in the active monitoring group did not receive active treatment and thus avoided the side effects of treatment.

Did you find this page helpful?

Information provided on this website is not a substitute for medical advice

Call 000 for emergency services

If you or someone you know needs urgent medical attention.

Call MensLine Australia on 1300 78 99 78 for 24/7 support

MensLine Australia is a telephone and online counselling service for men with emotional health and relationship concerns.

Sign up to our newsletter

We release two monthly newsletters – one written for men, family and friends, and another for health practitioners.

Your preferred mailing list

Your name

Your email

Stay up to date


Healthy Male acknowledges the traditional owners of the land. We pay our respects to elders past, present and future. We are committed to providing respectful, inclusive services and work environments where all individuals feel accepted, safe, affirmed and celebrated.


Healthy Male is funded by the Australian Government Department of Health and Aged Care. This website does not host any form of advertisement. Information provided on this website is not a substitute for medical advice.

Trusted information partner of