Clinical Research Directory

Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer

Sponsor: Centre Hospitalier Universitaire de Liege

Summary

\*Rationale : Active surveillance of prostate cancer helps to avoid the morbidity associated with curative radical prostatectomy /radiotherapy in patients with early stage disease. However, at 5 years and 15 years, respectively 35 % and nearly 50 % of patients require rescue interventional treatments. Numerous Phase II trials have reported using focal treatments (focused on the macroscopic tumor only while not involving the whole prostatic gland) in order to reduce the morbidity due to recurrence as well as the high anxiety rates under observation only. Stereotactic radiotherapy (highly focused radiotherapy technic to reduce the risk of side effects) is being proposed in the same way as it does not require any anaesthesia, as opposed to all the other focal methods. The purpose of this trial is to evaluate whether focal stereotactic radiotherapy treatments could reduce the rate of rescue treatments among patients eligible to an active surveillance program at first. * Major Inclusion Criteria : * 1\. Early stage prostate adenocarcinoma (CAPRA score ≤ 5) * 2\. No major urinary problems * 3\. Active Surveillance possible * Major Exclusion Criteria : * 1\. Age at diagnosis \< 50 years * 8\. Androgen-deprivation therapy * 9\. Any cancer within the last 5 years except skin basocellular carcinoma or any uncontrolled cancer * Trial : Phase II randomized trial comparing Stereotactic Radiation Therapy focused on the macroscopic tumor or Active Surveillance as the control arm. * Main objective : to compare the rescue treatment rates between the two arms

Official title: Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer: a Multicentric Phase-II Randomized Trial

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