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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

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