The purpose of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer.
Comparative effectiveness research project. All newly diagnosed prostate cancer patients fulfilling the low risk definition, resident in Piedmont or in Valle D'Aosta regions, will be invited to participate. All enrolled patients will receive full and clear information about their prognosis together with a balanced synthesis of the benefits and risks of the available treatments (active surveillance or radical treatments). Specific objectives are: * To estimate, at a population level, the proportion of newly diagnosed prostate cancer at low risk, eligible for active surveillance, the proportion of those accepting to be enrolled in a cohort of active surveillance and the risk of abandoning the program during follow-up. * To compare the patients' and physicians' characteristics of those accepting to be managed within the active surveillance program with those preferring a radical treatment (either surgery or radiotherapy). * To compare, at a population level, the clinical outcomes, quality of life and costs associated to different treatment choices.
Study Type
OBSERVATIONAL
Enrollment
850
PSA testing (every 3 months, then every 6 after 30 months), clinical visit and DRE every 6 months, prostate biopsy after 1, 4 and 7 years
Radical prostatectomy (open, laparoscopic or robotic)
External radical radiotherapy or brachitherapy
Oncolgy Network of Piemonte and Valle d'Aosta - Turin
Turin, Italy
Treatment-Free Survival (TFS)
Proportion of patients in active surveillance program alive and not undergoing active treatment for prostate cancer.
Time frame: Up to 24 months
Quality of Life
Measured through validated questionnaire EORTC QLQ-C30 at baseline and every six months during the first 2 years.
Time frame: Up to 24 months
Quality of Life
Measured through validated questionnaire QLQ-PR25 at baseline and every six months during the first 2 years.
Time frame: Up to 24 months
Quality of Life
Measured through validated questionnaire IPSS at baseline and every six months during the first 2 years.
Time frame: Up to 24 months
Quality of Life
Measured through validated questionnaire IIEF-5 at baseline and every six months during the first 2 years.
Time frame: Up to 24 months
Quality of Life
Measured through validated questionnaire HADS at baseline and every six months during the first 2 years.
Time frame: Up to 24 months
Quality of Life
Measured through validated questionnaire EuroQol-5D at baseline and every six months during the first 2 years.
Time frame: Up to 24 months
Quality of Life
Measured through validated questionnaire MHLC -Form C at baseline and every six months during the first 2 years.
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High intensity focal ultrasound, cryotherapy, others
Time frame: Up to 24 months
Cost-effectiveness
Incremental cost-effectiveness ratio calculated as the ratio between difference in costs and difference in QALYs (Quality Adjusted Life Years, from EQ-5D) among the treatment groups, during the first 2 years after diagnosis
Time frame: Up to 24 months