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

NCT05884632 | Recruiting

• 1 other identifier: 2022-51
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Acute genitourinary toxicity

  90 days from the RT treatment.

• Late toxicity

  From 90 days after the RT treatment until 24 months

• QLQ-C30

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

• Biochemical failure

  24 months

• Time to biochemical failure

  24 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

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

Interventions

Daily Adaptive RadioTherapy 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

Treatment arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, 37024, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Luca Nicosia

  IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elvia Malo

CONTACT

+390456014854; ricerca.clinica@sacrocuore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

IT (1)