SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer (SAFO)

Fractionated Stereotactic Ablative Body Radiotherapy (SBRT) With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer

Stereotactic ablative Body Radiotherapy (SBRT) is an advanced radiation technique that allows for precise delivery of higher radiation doses in fewer treatment sessions, resulting in a shorter overall treatment duration. The available clinical evidence suggests that SBRT is highly effective in controlling localized prostate cancer (PCa) with acceptable side effects.

On the other side, dose escalation is a commonly employed strategy in radiotherapy for prostate cancer. Recent studies have confirmed a dose-response relationship, demonstrating improved biochemical control with focal dose escalation to the identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) of the prostate.

The hypothesis of this study is that the combination prostate SBRT with focal dose intensification on the DIL with preservation of the prostatic urethra, would lead to a higher probability of local control without a significant increase in toxicity compared to standard clinical practice.

This is a prospective single-arm phase II study designed to evaluate the effectiveness, safety and impact on quality of life of focal dose intensification using SBRT technology and extreme hypofractionated radiotherapy.

Study Overview

• Status: Recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boost

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Almudena Zapatero, PhD; Phone Number: +34915202315; Email: almudena.zapatero@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Recruiting
    • La Princesa University Hospital, Health Research Institute, Madrid
    • Contact: Almudena Zapatero, PhD; Phone Number: +34915202315; Email: almudena.zapatero@salud.madrid.org
    • Principal Investigator: Almudena Zapatero, PhD
    • Sub-Investigator: Pablo Castro, BS
    • Sub-Investigator: Maria Roch, BS
    • Sub-Investigator: Pablo Rodriguez Carnero, MD
    • Sub-Investigator: Leopoldo Cogorno, MD
    • Principal Investigator: Alfonso Gomez Iturriaga, PhD
    • Sub-Investigator: David Büchser Garcia, MD
    • Sub-Investigator: Sara Carroceda, MD
    • Sub-Investigator: Alexandra Stoica, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate
• Primary localized PCa, cN0 and cM0, intermediate or high-risk disease according to NCCN 2023
• Signed written informed consent for this study
• T2-T3a clinical stage with visible DIL on mpMRI
• ECOG 0-1
• Desirable prostate volume (not mandatory) < 80 cc or > 80 cc if urinary function is preserved and dosimetrically feasible
• IPSS ≤ 18 (International Prostate Symptom Score)

Exclusion Criteria:

• Unresolved previous prostatitis, symptomatic urethral stenosis
• Bilateral hip prosthesis
• T3b-4 clinical stage or N1
• M1 (presence of distant metastases)
• Previous surgery at the prostate level (Transurethral Resection of the Prostate) within the last 6 months

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: SBRT with mpMRI guided focal boost; SBRT 36.25 Gy in 5 sessions of 7.25 Gy to the entire prostate (including seminal vesicles) with a DIL simultaneous integrated focal boost (SIB) up to 50 Gy in 5 sessions, with partial protection of the prostatic urethra and bladder trigone.

Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boost; Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions of 7.25 Gy to the entire prostate (including seminal vesicles) using VMAT; mpMRI defined DIL was simultaneously boosted up to 50 Gy in 5 sessions to the mpMRI identified DIL.; Additional urethra and bladder trigone sparing constrains; Daily IGRT with cone beam CT and intrafraction gold-seeds fiducial tracking; Other Names: SABR with SIB; SBRT focal intensification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical progression-free survival	Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)	3 years
Local control	Disappearance of suspicious image on mpMRI.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of acute urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale	Every urinary event occurring within 3 months from treatment completion will be defined as "acute event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)	90 days
Incidence and severity of acute rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale	Every rectal event occurring within 3 months from treatment completion will be defined as "acute event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)	90 days
Incidence and severity of late urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale	Every urinary event occurring after 3 months from treatment completion will be defined as "late event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)	2 years
Incidence and severity of late rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale	Every rectal event occurring after 3 months from treatment completion will be defined as "late event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)	2 years
Patient reported outcomes and quality of life assessment	Impact on Quality of life affecting the genitourinary, gastrointestinal, sexual and hormonal domains using the EPIC-26 short form (International Prostate Symptom Score (IPSS) and Expanded Prostate Index Composite-26	2 years

Collaborators and Investigators

• Sponsor: Almudena Zapatero

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: SBRT Focal SAFO

Drug and device information, study documents

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