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

September 25, 2023 updated by: Almudena Zapatero

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Recruiting
        • La Princesa University Hospital, Health Research Institute, Madrid
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 years
Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)
3 years
Local control
Time Frame: 12 months
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
Time Frame: 90 days

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
Time Frame: 90 days

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
Time Frame: 2 years

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
Time Frame: 2 years

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
Time Frame: 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Almudena Zapatero

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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