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.

Sex

Male

Minimum age

40 Years

Inclusion Criteria:

* 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 entry

Exclusion Criteria:

* N1 patients are ineligible, as are those with lymph node (LN) enlargement \> 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative.
* Gross residual disease in the prostate fossa based on imaging evidence, unless biopsy proven not to contain cancer.
* Prior radiation of any kind to the prostate gland or pelvis
* Prior brachytherapy is not allowed
* History of inflammatory colitis or other active severe comorbidities
* Patients who are on immunosuppressant medication