RecruitingNot ApplicableNCT05884632

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


Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Enrollment

184 participants

Start Date

Apr 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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;
  • Informed consent to trial's participation and personal data treatment.

Exclusion Criteria3

  • Age \<18 years old;
  • Adjuvant radiotherapy;
  • Previous radiation in the same anatomical site.

Interventions

RADIATIONDaily Adaptive RadioTherapy

Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy


Locations(1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

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NCT05884632


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