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

Prostate Cancer Clinical Trial

— DART-PHASER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884632
• Other study ID #: 2022-51
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: April 30, 2030

Study information

• Verified date: May 2023
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: Elvia Malo
• Phone: +390456014854
• Email: ricerca.clinica[@]sacrocuore.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: April 30, 2030
• Est. primary completion date: April 30, 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria di Negrar	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	Biochemical failure	PSA raise after RT from nadir	24 months
Secondary	Time to biochemical failure	Time between salvage RT and biochemical failure	24 months
Secondary	Local in-field relapse	Local in-field relapse evaluated with PET-CT or RM	24 months
Secondary	Metastases-free survival	Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise	24 months