Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence

Condition(s) studied

Investigational drug(s) / intervention(s)

SDRT: Salvage Single Dose Radiation Therapy (SDRT) to the prostate bed up to 17 Gy

Study summary

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

Primary outcome measure(s)

• Number of participants with acute treatment-related adverse events as assessed by CTCAE v. 5.0 — 3 months
  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.

Trial sites (1)

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