Localised prostate carcinoma: active monitoring is no worse than surgery or radiotherapy
In the case of early prostate cancer, active surveillance prevents just as many deaths as surgery or radiotherapy. This is confirmed by 15-year data from the large randomised 'ProtecT' study.
What is the ProtecT trial?
- Prostatectomy or radiotherapy reduced the incidence of metastases, and the local progression + long-term androgen deprivation therapy by half. But when compared to active surveillance, it did not translate into differences in cancer mortality after 15 years.
- 97 out of 100 men in the ProtecT study survived their PSA-detected prostate cancer on average 15 years after diagnosis, regardless of whether they received active surveillance, radiotherapy and surgery.1
- The authors single out that the result underlines the long natural course of this disease.2
Data that changes standard practice
"This is a turning point in the treatment of prostate cancer; many scientists have called it the largest trial ever. [...] It showed no difference in survival between the different treatment groups, which is an essential finding for counselling patients with a new diagnosis of prostate cancer," said Prof Suneil Jain, from the Queen's University of Belfast, an internationally renowned expert in the treatment of prostate cancer with the latest radiotherapy and systemic therapies.4
The three-arm ProtecT study (Prostate Testing for Cancer and Treatment) involved 82,429 men aged 50-69 who agreed to undergo a PSA test. Of these, 2,664 were diagnosed with localised prostate cancer, and of this group, 1,643 agreed to be randomly assigned to active surveillance, radical prostatectomy, or radiotherapy.
After 10 years of follow-up, there were no differences in disease-specific mortality between the treatment arms.
What is the best approach for men with localised prostate cancer?
Compared to active surveillance, surgery and radiotherapy reduced the risk of progression by half. But these treatments were associated with damage to sexual function and continence. Urinary incontinence and sexual function were worst in the prostatectomy cohort. In the radiotherapy group, sex life was also impaired, but not as frequently as in the surgery group. However, faecal incontinence was more common after radiotherapy.
Just over half (55%) of the men in the "watch&wait" cohort switched to radical treatment, but just under half (44%) remained disease-free and were able to avoid the treatments and their side effects.
The study found that overall long-term quality of life was similar in all groups.5 As expected, men under active surveillance experienced a gradual decline in urinary and sexual function over time. The researchers concluded that longer follow-up is needed to determine the most effective treatment for localised prostate cancer in terms of lifespan.
Latest data after 15 years: low cancer-specific mortality, regardless of procedure
"After a median follow-up of 15 years, we can now evaluate the results of this Herculean task," read a related editorial in the New England Journal of Medicine in 2023.6 The data published that year confirmed the trends of the previous analyses. Even after 15 years, the number of deaths from prostate cancer in the 'ProtecT' study remained low, regardless of which approach was chosen: in the group with active surveillance, 3.1% died from their prostate cancer; in the prostatectomy group it was 2.2% and in the radiotherapy group 2.9% (no significant difference between the groups). In contrast, 21.7% of the study participants died from other causes and this number was also similar in all three groups.2 The cancer-specific mortality of 3% has also been documented in other studies on prostate cancer.7
"I didn't know what to expect. I think I was prepared for any outcome. The results are now really helpful when I have a conversation with patients and their partners, as we now have concrete data on what might happen with individual treatment options," said lead author Prof Freddie Hamdy from the University of Oxford.4 He emphasises that the decision is always driven by the trade-off between benefit or chance of cure and treatment side effects. "Every man will have different priorities, but at least we can now help him by providing evidence to support his decision."
-
ProtecT Study (Prostate testing for cancer and Treatment) Newsletter Issue 16, 2023.
- Hamdy, F. C. et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. New England Journal of Medicine 388, 1547–1558 (2023).
- Hamdy, F. C. et al. Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT. Health Technol Assess 24, 1–176 (2020).
-
Active monitoring in early prostate cancer prevents as many deaths as surgery or radiotherapy, new research shows.
- Donovan, J. L. et al. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment. NEJM Evidence 2, EVIDoa2300018 (2023).
- Sartor, O. Localized Prostate Cancer — Then and Now. New England Journal of Medicine 388, 1617–1618 (2023).
- Islami, F. et al. Annual Report to the Nation on the Status of Cancer, Part 1: National Cancer Statistics. JNCI: Journal of the National Cancer Institute 113, 1648–1669 (2021).