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Trial Title:
SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer
NCT ID:
NCT05919524
Condition:
Prostate Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single group assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Prostate SBRT (stereotactic body radiation therapy) with focal boost
Description:
- 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
Arm group label:
SBRT with mpMRI guided focal boost
Other name:
SABR with SIB
Other name:
SBRT focal intensification
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.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
La Princesa University Hospital, Health Research Institute, Madrid
Address:
City:
Madrid
Zip:
28006
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Almudena Zapatero, PhD
Phone:
+34915202315
Email:
almudena.zapatero@salud.madrid.org
Investigator:
Last name:
Almudena Zapatero, PhD
Email:
Principal Investigator
Investigator:
Last name:
Pablo Castro, BS
Email:
Sub-Investigator
Investigator:
Last name:
Maria Roch, BS
Email:
Sub-Investigator
Investigator:
Last name:
Pablo Rodriguez Carnero, MD
Email:
Sub-Investigator
Investigator:
Last name:
Leopoldo Cogorno, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alfonso Gomez Iturriaga, PhD
Email:
Principal Investigator
Investigator:
Last name:
David Büchser Garcia, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sara Carroceda, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alexandra Stoica, MD
Email:
Sub-Investigator
Start date:
August 1, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Almudena Zapatero
Agency class:
Other
Source:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919524
