Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-90
SponsorUniversity of Milano Bicocca

About this trial

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

Eligibility criteria

Qualifiers

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)

Disqualifiers

N1 and or M1 patients

Macroscopic local relapse at pelvic MRI.

Prior radiation of any kind to the prostate gland or pelvis

Prior brachytherapy

Trial design

Treatments tested in this trial

  • SDRT

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators