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HDR Brachytherapy Plus Stereotactic Ablative Prostate Radiotherapy for Patients With Intermediate and High-risk Prostate Cancer

NCT04523896 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-08-24

No results posted yet for this study

Summary

Dose escalation is nowadays a standard strategy in radiotherapy for prostate cancer. Besides, it is believed that due to the radiobiology characteristics of prostate cells (low alpha/beta ratio), the delivery of higher radiation doses per fraction could theoretically improve the efficacy of the treatment. In this context, the combination of prostate brachytherapy and external beam radiotherapy (EBRT) has proven to be the most effective method of dose escalation significantly improving disease control in randomized clinical trials. Unfortunately, this strategy is also associated with an increased risk of acute and late adverse events compared to conventional EBRT alone. It has been proposed that this increase in adverse events could be related to the use Low-Dose-Rate (LDR) brachytherapy and that High-Dose-Rate (HDR) brachytherapy (a more modern and accurate procedure) could reduce this risk.

On the other hand, Stereotactic Ablative Radiotherapy (SABR) is a high-precision radiation technique that allows the delivery of higher doses per fraction in fewer sessions, reducing the total treatment time.

The investigators hypothesized that the combination of two highly conformal radiation techniques (HDR brachytherapy and SABR) could be well tolerated, while reducing total treatment time and therefore improving patient quality of life.

This is a single arm Phase II clinical trial designed to test the feasibility, tolerability and impact on quality of life of the combination of High-Dose-Rate prostate brachytherapy and SABR for patients with intermediate and high-risk prostate cancer.

Conditions

  • Prostatic Neoplasm

Interventions

RADIATION

Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapy

\- Brachytherapy: Real time HDR prostate brachytherapy using a MRI-trans-rectal ultrasound image fusion protocol: single fraction of 15 Gy. Planning software: Oncentra prostate (Nucletron) \- External beam radiotherapy: Stereotactic ablative radiation therapy (SABR): 5 session in 5 consecutive days, 5 Gy per fraction to the prostate. Intra-fraction gold seeds monitoring using Auto beam Hold solution (Varian) Planning software: Eclipse (Varian).

Sponsors & Collaborators

  • David Büchser

    lead OTHER_GOV

Principal Investigators

  • David Büchser, MD · Biocruces Bizkaia Health Research Institute/ Cruces University Hospital

  • Alfonso Gomez-Iturriaga, MD, PhD · Biocruces Bizkaia Health Research Institute/ Cruces University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2021-07-31
Completion
2023-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523896 on ClinicalTrials.gov