NCT01795365

Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Active Surveillance manages selected men with prostate cancer expectantly with curative intent. This means men are carefully selected and subsequently actively observed in order to have the possibility to offer them curative treatment once the tumor seems to progress. The goal of this study is to validate the treatment option Active Surveillance in men with localized, well differentiated prostate cancer, in order to limit the amount of overtreatment. A number of key points will be studied, such as the pathological findings in radical prostatectomy specimens, and the effect of expectancy on the quality of life.

Detailed description

Objectives: Primary \- To evaluate the equivalence of the time on active surveillance before an active treatment between group Epstein + and the expanded active surveillance group (Epstein -) Secondary * To evaluate the role of diffusion-weighted MRI (DW-MRI) in the initial diagnosis and the follow-up of patients under active surveillance * To evaluate the role of BCAR-1 to predict the clinical outcome of localized prostate cancer * To evaluate the proportion of patients who discontinued active surveillance * To evaluate the mortality at 10, 15 and 20 years from the inclusion in the study * To evaluate the time to radical treatment * To evaluate the time to metastatic disease * To evaluate patients quality of life

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
OTHER	Active surveillance

Timeline

• Start date: 2012-12-01
• Primary completion: 2018-07-01
• Completion: 2018-07-26
• First posted: 2013-02-20
• Last updated: 2018-09-28

Locations

1 site across 1 country: Switzerland