Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility
Subjects of male sex ≥ 18 years of age.
Subjects have freely signed the pertinent informed consent before the beginning of the study
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)
Detectable post-prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL either (1) persistently detectable post-operatively or (2) developing biochemical recurrence after prostatectomy (initially undetectable)
N1 and or M1 patients
Macroscopic local relapse at pelvic MRI.
Prior radiation of any kind to the prostate gland or pelvis
Prior brachytherapy
Patients with biochemical relapse following radical prostatectomy
Cohort
Prospective
SDRT
RadiationSalvage Single Dose Radiation Therapy (SDRT) to the prostate bed up to 17 Gy
Number of participants with acute treatment-related adverse events as assessed by CTCAE v. 5.0
To prospectively evaluate the cumulative incidence of acute (\< 90 days from the end of treatment) genitourinary (GU) and gastrointestinal (GI) treatment-related toxicities and adverse events. Toxicity assessments are performed at baseline, end of treatment, and at 1, 2, and 3 months after radiotherapy.
Number of participants with late treatment-related adverse events as assessed by CTCAE v.5.0
To prospectively evaluate the cumulative incidence of late (≥ 6 months) genitourinary (GU) and gastrointestinal (GI) treatment-related toxicities and adverse events.
QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-CP) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL
To measure symptom scores for each QOL domain (urinary incontinence, urinary irritative/obstructive, bowel, sexual) after SDRT by EPIC-CP Questionnaire
Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst)
To assess urinary continence after postoperative SDRT using ICIQ-SF
Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best)
To assess erectile function after postoperative SDRT using IIEF 5
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