Prolaris – a powerful test for prostate cancer prognosis

Worldwide, more than one million men are diagnosed with prostate cancer each year. The severity of the cancer can range from indolent − a cancer that wouldn’t become symptomatic in a patient's lifetime – to aggressive, and potentially fatal. 

Existing samples lead to ground-breaking new research

It’s extremely difficult to accurately predict how prostate cancer will progress. In the past, many prostate cancer patients with clinically localised disease were left with an intermediate prognosis. It was uncertain whether they needed radical treatment.

At that time, management was based on a range of measurements, but it was clear that clinicians needed better markers, so that in some cases they could avoid unnecessary radical treatment of the sort that was required for patients with high morbidity.

Led by Professor Jack Cuzick, a unique collaboration of prostate cancer experts from the UK and USA formed the Transatlantic Prostate Group (TAPG) in 1999. The group looked at a predefined cell cycle progression score (CCP), and considered its prognostic value. There was no direct patient involvement; hospital sites participating in the TAPG study sent pathology tissue biopsy slides and blocks to the central coordinating team at the Centre for Cancer Prevention.

These slides and blocks were analysed by the study reference pathologist and underwent biomarker testing to determine what factors could better predict the clinical progression of prostate cancer.

CCP as a prognostic marker

The resulting paper showed the CCP score was a robust prognostic marker, which could, with additional validation, help to determine appropriate treatment for prostate cancer patients.

A 2012 TAPG study sought to find ways to make this knowledge helpful in a clinical setting, and concluded that the CCP score was the strongest independent predictor of cancer death outcome yet described.

The definitive research project was a needle biopsy-based validation study that showed that for conservatively managed patients, the CCP score was extremely useful in predicting the likelihood of death from prostate cancer.

This gives clinicians valuable information before they begin treatment – can the patient be safely managed conservatively, thereby avoiding unnecessary or radical treatment? Does the patient need adjuvant endocrine or chemotherapy? Now doctors can plan and treat accordingly.

How has this changed the treatment of prostate cancers?

Prolaris has helped many thousands of men and their physicians make the difficult decision about whether to choose active surveillance or radical therapy (with its associated morbidity) to treat clinically localised prostate cancer.

An independent study has shown that there was a 37.2% drop in interventional treatment when using Prolaris, with a 49.5% reduction in surgical interventions and a 29.5% reduction in radiation treatment.

Following Professor Cuzick’s 2015 validation publication, the Tufts Health Plan (a leading health plan in the north east USA with more than 1,000,000 members) agreed to provide coverage of Prolaris to its members diagnosed with localised prostate cancer.

In 2017, Prolaris was the first and only genetic test to receive Medicare approval for favourable intermediate prostate cancer patients, and by mid-2018 Prolaris had insurance coverage for 50% of US prostate cancer patients. In the USA, more than 60,000 patients have been tested.

Patient access to Prolaris in Europe

Prolaris has now received European CE marking for the specimen collection set and the entire test (all processes, consumables, equipment and software).

Under commission from NHS England, the National Institute for Health and Care Excellence issued a Medtech Innovation Briefing on Prolaris as part of the NHS five-year Forward View. Since January 2018, BUPA members in the UK have been covered for Prolaris use.

Improving health economics

An economic study found that the Prolaris test reduced costs by US$2,850 per patient over ten years. For a health plan with 10,000,000 members, this translates to more than US$16,000,000 in savings, with two-thirds of the savings achieved in the first year after testing.

Commercial success of Prolaris

As a result of the Medicare coverage expansion to intermediate-risk patients, revenue from the Prolaris test nearly doubled in the quarter ending 31 March 2018, from US$3,400,000 to US$6,500,000, compared with the same quarter in the previous year. Prolaris testing revenue in the 2018 fiscal year reached US$20,900,000.