Urethral Sparing clinical trials

Stereotactic Hypofractionated Accelerated Radiotherapy Post-Prostatectomy

The present phase I trial evaluates the feasibility of a postoperative stereotactic hypofractionated external beam radiation therapy delivered in patients who underwent radical prostatectomy with adverse pathological features or early biochemical failure. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely. Eligible patients for this study are those with: - Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy) - Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle involvement - Undetectable post-radical prostatectomy PSA that becomes detectable and then increases on 2 subsequent measurements (PSA of > 0.1 - ≤ 2.0 ng/mL) - Life expectancy: 10 years - ECOG performance status of 0 -1 - No distant metastases, based on the following workup within 60 days prior to registration - Magnetic resonance imaging (MRI) of the pelvis - PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients with biochemical recurrence - Patients can be on androgen deprivation therapy - Ability to understand and willingness to sign a study-specific informed consent prior to study. Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.