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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Daily Adaptive RadioTherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>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 | Radiation: Daily Adaptive RadioTherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 days from the RT treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months | 
| Biochemical failure | PSA raise after RT from nadir | 24 months | 
| Time to biochemical failure | Time between salvage RT and biochemical failure | 24 months | 
| Local in-field relapse | Local in-field relapse evaluated with PET-CT or RM | 24 months | 
| Metastases-free survival | Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise | 24 months |