Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorIRCCS Sacro Cuore Don Calabria di Negrar

About this trial

This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.

Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.

Eligibility criteria

Qualifiers

Age ≤ 80 years;

Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);

Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA <0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;

No distant metastases (M0) diagnosed with PSMA-PET-CT;

Disqualifiers

Age <18 years old;

Adjuvant radiotherapy;

Previous radiation in the same anatomical site.

Trial design

Treatments tested in this trial

  • Daily Adaptive RadioTherapy

Treatment groups

184 Participants
are divided into 1 treatment group