The article presenting the results of the START study has just been published in the international journal JAMA Network Open, which since 2015 has followed over 900 patients with a new diagnosis of low-risk prostate cancer, involving all the main urology and radiotherapy facilities and pathological anatomy of Piedmont and Valle d'Aosta.
The study, promoted by the Oncology Network of Piedmont and Valle d'Aosta thanks to funding from the Compagnia di San Paolo Foundation, was coordinated by the Clinical Epidemiology SSD of the AOU Città della Salute e della Scienza of Turin - CPO Piedmont. This is one of the rare studies conducted across an entire inter-regional hospital network to offer patients with a new diagnosis of low-risk prostate cancer the possibility of choosing between traditional radical treatments (surgery or radiotherapy) and an active surveillance programme. , based on regular clinical, laboratory and, with longer intervals, instrumental checks.
Before the START study, active surveillance was rarely offered, by a few centers, and only to very informed and motivated patients. This difficulty in proposing active surveillance depended on several factors, including: uncertainty about long-term results, the fear of incurring medico-legal disputes, the heterogeneity of approaches between different specialists and an understandable difficulty on the part of patients in simultaneously receiving a cancer diagnosis without indication of active treatment.
Thanks to the START study it was possible to agree between the urology, radiotherapy and pathological anatomy centers of the two regions on a common protocol for offering the choice between these different treatment strategies to patients with new diagnoses of prostate tumors at low risk of progression, such as recommended for years by all international and national guidelines, including a 2009 regional guideline. The START protocol provided for a clear explanation of the diagnosis, prognosis and different treatment alternatives, including active surveillance. All this information was also explained in a leaflet given to patients which summarized the benefits and risks of the different alternatives in understandable terms to enable an informed decision.
The most relevant result of the study is that, after being correctly informed, over 80% of patients opted for active surveillance. The data collected during the study, which followed all patients over the years, regardless of their choice, confirmed an identical probability of survival 5 years after diagnosis between the different therapeutic choices, in line with the 15-year results of PROTECT , the most important international study available so far. Among the factors that contributed to reassuring doctors and patients in the choice of active surveillance, an important role was played by the multidisciplinary discussion of cases between the various specialists (in line with the approach adopted by the Oncology Network of Interdisciplinary Care Groups, GIC) and the possibility of pathologists in each hospital asking for confirmation of the low-risk characteristics of the biopsy from colleagues who are more expert on these diagnoses in other hospitals.
There remain some aspects that should be improved, in particular the application of the criteria for recommending the abandonment of active surveillance and the transition to radical treatment (which often occurred too hastily and with a prevalent surgical). Through the study, information was also collected on the quality of life of the patients who made the various therapeutic choices; these data are currently being analyzed in depth and will be published shortly.
Finally, a topic of great importance will be the maintenance of this new therapeutic strategy over time, after the conclusion of the START study, to ensure an informed and conscious choice of patients and a careful program of active surveillance in the future too.
The START experience clearly demonstrates that research initiatives within the National Health Service are able to achieve results of international scientific interest and at the same time contribute to improving the quality and equity of care and positive collaboration among the health facilities of the Oncology Network.