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

IRCCS Sacro Cuore Don Calabria di Negrar184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

184

Conditions

Prostate Cancer

Interventions

Daily Adaptive RadioTherapy

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Acute gastrointestinal toxicity

Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade ≥G2.

Time frame: 90 days from the RT treatment

Secondary Outcomes

Acute genitourinary toxicity

Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any genitourinary event occurred within 90 days from the RT treatment.

Time frame: 90 days from the RT treatment.

Late toxicity

Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, late toxicity will be defined as any event (genitourinary and gastrointestinal) occurred from 90 days after the RT treatment.

Time frame: From 90 days after the RT treatment until 24 months

QLQ-C30

Patient-reported outcomes will be assessed via the EORTC global (QLQ-C30) questionnaires at screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months

Time frame: At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months

Biochemical failure

PSA raise after RT from nadir

Time frame: 24 months

Time to biochemical failure

Time between salvage RT and biochemical failure

Time frame: 24 months

Local in-field relapse

Local in-field relapse evaluated with PET-CT or RM

Time frame: 24 months

Metastases-free survival

Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise

Time frame: 24 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts