Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients (DART-PHASER)

IRCCS Sacro Cuore Don Calabria di Negrar

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Radiation: Daily Adaptive RadioTherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05884632

2022-51

Details and patient eligibility

About

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.

Enrollment

184 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria