Spots Global Cancer Trial Database for PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)

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Trial Identification

Brief Title: PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)

Official Title: PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)

Study ID: NCT03663218

Conditions

Prostate Cancer

Interventions

Dose escalation

Study Description

Brief Summary: Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.

Detailed Description: Patients with a diagnosis of high risk prostate cancer with a Gleason score of 8 or greater are eligible for this trial. The study will enroll 20 subjects in 3 years. This is a single arm study and the primary objectives is to assess if a patient can undergo a radical prostatectomy after SBRT without a post-operative grade 3 or higher toxicity (according to Clavien-Dindo Classification) at 30 days. Secondary objectives are to assess acute toxicity and quality of life scores. Exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.