CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 46 target
Drug / intervention
SBRTradiation
Likely dose
Not stated in record
Key inclusion· 9
  • Men aged ≥18 years
  • Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
  • Gleason score 3+4 or 4+3 (Grade groups 2 or 3)
  • MRI stage T3a or less
Key exclusion· 9
  • Contraindications to MRI (e.g. pacemaker, metal implants, claustrophobia)
  • IPSS ≥13
  • Post-void residual >100 mls
  • Prostate volume >80cc

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04595019
NCT04595019N/ARecruitingOn TrackUpdated 48mo ago
Long Recruiting

The HERMES Trial Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer. A Phase II Randomised Trial of Ultrahypofractionated Stereotactic Body Radiotherapy in Men With Localised Prostate Cancer

Institute of Cancer Research, United Kingdom·interventional·Posted Oct 20, 2020·Updated Jun 13, 2022

In Brief

A clinical study evaluating SBRT for Prostate Cancer. Currently recruiting, targeting 46 participants across 1 site.

Detailed Summary

The purpose of this research is to investigate whether stereotactic body radiotherapy (SBRT), precise X-ray treatment, is best given in five treatments (also called fractions) over 10 days or in two treatments over 8 days. SBRT is an accurate way to deliver a high dose of radiotherapy to the prostate in a smaller number of doses. We have considerable experience with 5-dose SBRT and now wish to examine the feasibility and safety of delivering treatment over two, larger, doses. Previous work has shown it is theoretically possible to deliver two fraction SBRT on the MR-linac and previous studies have shown internal radiotherapy (brachytherapy) administered in two fractions to be a safe option for patients with low-risk prostate cancer. All treatment within this trial will be delivered on a new, state of the art, radiotherapy machine called an MR-linac (Magnetic Resonance Linear Accelerator). It puts together an MRI scanner with a radiotherapy treatment machine called a Linear Accelerator. The use of the MR-linac means there is no extra radiation dose given when taking images (unlike computerized tomography (CT) scans or X-ray), enabling us to adapt the radiotherapy plan each day if needed to more precisely target the prostate. The results of the study will enable us to find out if the new, shorter treatment (2 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited Kingdom
Collaborators--

Timeline

N/ARecruiting
20212022202320242025202620272028
First PostedOct 20, 2020
Enrollment StartJul 29, 2021
Primary CompletionApr 30, 2028
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 5.7 years agoPrimary completion in 1.8 years

Interventions

SBRTradiation

Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.