Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919524
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-06-05
Brief Title:
SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer
Sponsor:
Almudena Zapatero
Organization:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Overview
Official Title:
Fractionated Stereotactic Ablative Body Radiotherapy SBRT With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFO
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None