NCT05919524: SAFO

SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer

Status unknown NA Last updated 26 September 2023

What this trial tests

NA trial testing Prostate SBRT (stereotactic body radiation therapy) with focal boost in Prostate Adenocarcinoma in 27 participants. Status unknown.

Timeline

1 August 2023

Primary endpoint
1 July 2024

30 June 2025

Quick facts

Lead sponsor	Almudena Zapatero
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 August 2023
Primary completion	1 July 2024
Estimated completion	30 June 2025
Sites	1 location across Spain

Drugs / interventions tested

• Prostate SBRT (stereotactic body radiation therapy) with focal boost

Conditions studied

• Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →

Sponsor

Almudena Zapatero

Who can join

18 and older, male only, with Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. State of the art and future challenges of urethra-sparing stereotactic body radiotherapy for prostate cancer: a systematic review of literature.
   Le Guevelou J, Bosetti DG, Castronovo F, Angrisani A, et al · · 2023 · cited 24× · PMID 37668718 · DOI 10.1007/s00345-023-04579-6
2. Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial.
   Zapatero A, Castro P, Roch M, Carnero PR, et al · · 2024 · cited 2× · PMID 38702761 · DOI 10.1186/s13014-024-02440-7
3. Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial
   Zapatero A, Castro P, Roch M, Carnero P, et al · · 2024
4. Functional Imaging Guided Stereotactic Ablative Body Radiotherapy (SABR) with Focal Dose Escalation and Bladder Trigone Sparing for Intermediate and High-Risk Prostate Cancer: STUDY PROTOCOL FOR PHASE II SAFO TRIAL
   Zapatero A, Castro P, Roch M, Carnero PR, et al · · 2024 · DOI 10.21203/rs.3.rs-3894247/v1