SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer
NCT ID: NCT05919524
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
27 participants
INTERVENTIONAL
2023-08-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Almudena Zapatero
OTHER
Responsible Party
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Almudena Zapatero
Principal Investigator and Sponsor
Locations
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La Princesa University Hospital, Health Research Institute, Madrid
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Zapatero A, Castro P, Roch M, Carnero PR, Carroceda S, Rosciupchin AES, Hernandez SH, Cogorno L, Iturriaga AG, Garcia DB. 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. Radiat Oncol. 2024 May 3;19(1):54. doi: 10.1186/s13014-024-02440-7.
Other Identifiers
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SBRT Focal SAFO
Identifier Type: -
Identifier Source: org_study_id
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