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

Sponsor
Almudena Zapatero (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05919524
Collaborator
(none)
27
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boost
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single group assignmentSingle group assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Fractionated Stereotactic Ablative Body Radiotherapy (SBRT) With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Biochemical progression-free survival [3 years]

      Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)

    2. Local control [12 months]

      Disappearance of suspicious image on mpMRI.

    Secondary Outcome Measures

    1. Incidence and severity of acute urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale [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)

    2. Incidence and severity of acute rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale [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)

    3. Incidence and severity of late urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale [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)

    4. Incidence and severity of late rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale [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)

    5. Patient reported outcomes and quality of life assessment [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 La Princesa University Hospital, Health Research Institute, Madrid Madrid Spain 28006

    Sponsors and Collaborators

    • Almudena Zapatero

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Almudena Zapatero, Principal Investigator and Sponsor, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
    ClinicalTrials.gov Identifier:
    NCT05919524
    Other Study ID Numbers:
    • SBRT Focal SAFO
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Jun 26, 2023