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

NCT ID: NCT05884632

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2030-04-30

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Daily Adaptive RadioTherapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Nicosia

Role: PRINCIPAL_INVESTIGATOR

IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata

Locations

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elvia Malo

Role: CONTACT

ricerca.clinica@sacrocuore.it

+390456014854

Facility Contacts

Luca Nicosia, Doctor

Role: primary

luca.nicosia@sacrocuore.it

+39(0)456014800

Other Identifiers

2022-51

Identifier Type: -

Identifier Source: org_study_id