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

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 Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Daily Adaptive RadioTherapy

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvia Malo; Phone Number: +390456014854; Email: ricerca.clinica@sacrocuore.it

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy, 37024
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria di Negrar
      • Contact: Luca Nicosia, Doctor; Phone Number: +39(0)456014800; Email: luca.nicosia@sacrocuore.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
• Investigators: Principal Investigator: Luca Nicosia, IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2022-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No