Who this is for
High-risk localised prostate cancer means prostate cancer has not spread to distant organs, but still has features that may increase the chance of recurrence.
This article is for men with newly diagnosed high-risk localised or locally advanced prostate cancer whose scans show no evidence of cancer spread elsewhere in the body.
It may also be helpful for patients seeking prostate cancer treatment in Melbourne, Australia, or second opinions from Sri Lanka, Maldives, Indonesia or the Philippines.
Clinical observation
A 62-year-old man comes to see me after a PSA of 9 leads to further investigations. His MRI and PSMA PET scan suggest that the cancer is still confined to the prostate and surrounding region, with no evidence of distant metastases.
One of the first questions he asks is:
“If the cancer hasn’t spread, is surgery enough?”
Traditionally, treatment has focused on removing or irradiating the cancer and then monitoring closely. However, in their cancer journey to reduce the risk of recurrence years later.
This was the question explored in the recently published PROTEUS trial.
Importantly, while the results are encouraging, this treatment approach is not currently PBS funded in Australia, has not been incorporated into routine Australian practice, and remains an emerging treatment strategy rather than an established standard of care.
What the study tested
- Trial: PROTEUS
- Phase: III randomised placebo-controlled trial
- Patients: 2,109 men
- Centres: 184 centres
- Countries: 18 countries including Australia, the United States, Canada, the United Kingdom and multiple European nations
- Population: High-risk localised or locally advanced prostate cancer planned for radical prostatectomy
- Treatment arm: Apalutamide plus androgen deprivation therapy before and after surgery
- Control arm: Placebo plus androgen deprivation therapy before and after surgery
The goal was to determine whether earlier treatment intensification could reduce future recurrence and metastatic spread.
Key results
- Metastasis-free survival was improved.
At 5 years, 78.2% of men in the apalutamide group were alive without metastatic spread, compared with 73.5% in the control group. - The risk of metastasis or death was lower.
Adding apalutamide reduced the risk of metastatic spread or death by approximately 20%. - Event-free survival was also improved.
Men receiving apalutamide had fewer recurrence, progression or disease-related events during follow-up. - More men had little or no cancer remaining in the surgical specimen.
This occurred in 8.9% of men receiving apalutamide compared with 1.0% in the control group. - Side effects were more common.
More men had significant side effects in the apalutamide group, so patient selection remains important.
In simple terms, men who received apalutamide before and after surgery had better disease-control outcomes during follow-up.
They were less likely to experience recurrence, metastatic progression or other prostate cancer-related events.
However, this remains an emerging treatment strategy in Australia.
It is not currently PBS funded or routinely used for this indication, and longer-term overall survival data are still evolving.
What this means for you
This study is exciting because it challenges a long-held assumption in prostate cancer.
For many years, doctors often viewed surgery as the main treatment and considered additional therapies later if the cancer returned.
PROTEUS suggests that, for selected men with high-risk localised or locally advanced prostate cancer, earlier treatment intensification may improve disease control.
However, this is not yet routine care for most men in Australia.
This is a newly published study.
The treatment is not currently PBS funded for this indication, and longer-term overall survival data are still evolving.
For most men diagnosed today, the most important decision remains choosing the right primary treatment strategy.
That may include surgery, radiotherapy, hormone therapy, or a combined approach.
The decision should take into account MRI findings, PSMA PET findings, biopsy results, overall health and personal preferences.
For patients seeking prostate cancer treatment in Melbourne, Australia, or international second opinions from Sri Lanka, Maldives, Indonesia or the Philippines, the key message is simple.
The quality of the initial treatment plan matters.
Getting the diagnosis, staging and treatment sequence right from the beginning remains one of the most important factors influencing long-term outcomes.
Overall, high-risk localised prostate cancer is an area where treatment planning may become more personalised as new evidence continues to emerge.
Key takeaways
- High-risk localised prostate cancer does not always behave the same way
Some men may have a higher chance of recurrence even when scans show no distant spread. - Earlier treatment intensification may become important for selected patients
PROTEUS suggests that adding stronger treatment around the time of surgery may improve disease control in some men. - This is promising, but not routine care for everyone
In Australia, this approach is still emerging and should be discussed carefully with a specialist. - The first treatment plan matters
Accurate diagnosis, staging and treatment sequencing remain central to long-term prostate cancer care.
Key evidence
- Taplin ME, Gleave M, Shore ND, et al. Perioperative apalutamide in high-risk localized prostate cancer. N Engl J Med. Published online May 31, 2026. doi:10.1056/NEJMoa2603878
Frequently asked questions (FAQ)
- My PSA is 9. Does that mean I have high-risk prostate cancer?
Not necessarily. PSA is only one factor. The Gleason score, MRI findings, PSMA PET results, and clinical stage are often more important in determining risk.
- Does this study mean I should receive apalutamide?
No. The treatment is not routinely available for this indication and is not PBS funded in Australia.
- Is this treatment available in Australia?
Not as standard care. At present, PROTEUS should be viewed as promising emerging evidence rather than routine clinical practice.
- Should I delay treatment waiting for access to this drug?
In most cases, no. Established treatments such as surgery, radiotherapy, and androgen deprivation therapy already have strong long-term evidence supporting their use.
- Is surgery still an excellent treatment?
Absolutely. Surgery remains a highly effective curative treatment for many men with localised and locally advanced prostate cancer.
- What is the most important test before deciding on treatment?
For many men in 2026, the combination of a high-quality MRI scan and PSMA PET scan provides some of the most important information when planning treatment.
- Should I seek a second opinion?
A second opinion can be particularly valuable when the cancer is high-risk, locally advanced, or when there is uncertainty between surgery, radiotherapy, or combined treatment approaches.
Dr Dilanka De Silva
MBBS, MRCP(UK), MRCP(UK SCE Oncology), FRACP, PhD
Medical Oncologist & Cancer Genetics Physician
Memorial Sloan Kettering Cancer Center Fellow (New York, USA)