NCT03348722

Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer START

START (Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer): an Epidemiological Study of the Oncology Network of Piemonte and Valle d'Aosta (Italy)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 850 (actual)
• Sponsor: Rete Oncologica Piemonte, Valle d'Aosta · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatic Neoplasm

Interventions

Type	Name	Description
OTHER	Active surveillance	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
PROCEDURE	Radical prostatectomy	Radical prostatectomy (open, laparoscopic or robotic)
RADIATION	Radiotherapy	External radical radiotherapy or brachitherapy
PROCEDURE	Other radical treatments	High intensity focal ultrasound, cryotherapy, others

Timeline

• Start date: 2015-05-15
• Primary completion: 2021-12-31
• Completion: 2023-03-01
• First posted: 2017-11-21
• Last updated: 2023-03-31

Locations

1 site across 1 country: Italy