Description:
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.
Title
- Brief Title: Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
ICR-CTSU/2020/10070
- SECONDARY ID:
CCR5273
- SECONDARY ID:
285291
- NCT ID:
NCT04595019
Conditions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
5 fraction | Active Comparator | MRI-guided radiotherapy, 36.25 Gray (Gy) in 5 fractions (boost to 40 Gy over tumour/prostate CTV) over 10 days. | |
2 fraction | Experimental | MRI-guided radiotherapy, 24 Gy in 2 fractions (boost to 27 Gy over tumour/prostate CTV) over 8 days. | |
Eligibility Criteria
Inclusion Criteria:
1. Men aged ≥18 years
2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
3. Gleason score 3+4 or 4+3 (Grade groups 2 or 3)
4. MRI stage T3a or less
5. PSA <25 ng/ml prior to starting ADT (Androgen deprivation therapy)
6. Patients will be concurrently treated with androgen deprivation therapy (ADT) for at
least 6 months, as per standard of care. Men who need longer courses of ADT (maximum
12 months) will be considered on a case-by-case basis, and bicalutamide monotherapy is
accepted as an alternative to LHRH (luteinizing hormone-releasing hormone) analogues
if required.
7. WHO (World Health Organisation) Performance status 0-2
8. Ability of the participant understand and the willingness to sign a written informed
consent form.
9. Ability/willingness to comply with the patient reported outcome questionnaires
schedule throughout the study.
Exclusion Criteria:
1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant,
claustrophobia)
2. International Prostate Symptom Score (IPSS) 13 or higher
3. Post-void residual >100 mls
4. Prostate volume >80cc
5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel
disease) or preclude long term follow up
6. Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes
artefact on diffusion-weighted imaging
7. Previous pelvic radiotherapy
8. Patients needing 2-3 years of ADT due to disease parameters.
9. Previous invasive malignancy within the last 2 years excluding basal or squamous cell
carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming
cystoscopic follow up now negative) or small renal masses on surveillance.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Genitourinary (GU) toxicity |
Time Frame: | 12 weeks |
Safety Issue: | |
Description: | The proportion of patients experiencing CTCAE (Common Terminology Criteria for Adverse Events) Grade 2+ genitourinary (GU) toxicity from the start of radiotherapy up to 12 weeks post-treatment. |
Secondary Outcome Measures
Measure: | Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) toxicity |
Time Frame: | 12 weeks |
Safety Issue: | |
Description: | Physician-reported CTCAE GU and GI toxicity will be reported during treatment and at 12 weeks post-treatment will be summarised according to grade and treatment received using descriptive statistics at each time point. |
Measure: | Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) late toxicity |
Time Frame: | 1, 2 and 5 years |
Safety Issue: | |
Description: | Late toxicity (CTCAE) at 1, 2 and 5 years post-treatment will be summarised according to grade and treatment received at each time point. |
Measure: | Quality of life patient-reported outcomes |
Time Frame: | 12 weeks, 1, 2 and 5 years post treatment. |
Safety Issue: | |
Description: | Combined data from the IPSS (International Prostate Symptom Score), EPIC-26 (Expanded Prostate Index Composite-26), EQ-5D (EuroQol-5D) and IIEF-5 (International Index of Erectile Function) QOL instruments will be summarised. Domain scores from the quality of life patient-reported outcome tools will be derived using standard algorithms with missing data handled accordingly. Domain scores and individual items from the patient questionnaires will be presented graphically at each time point and summarised using descriptive statistics, separately for each treatment group. Changes from baseline will be assessed within treatment groups, and multiple regression models (e.g. ANCOVA, ordinal logistic regression or longitudinal models) will investigate patient and clinical factors that may be associated with change in patient-reported outcomes. |
Measure: | PSA (Prostate Specific Antigen) control and biochemical failure/progression |
Time Frame: | 2 and 5 years |
Safety Issue: | |
Description: | Time to event. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Institute of Cancer Research, United Kingdom |
Last Updated
October 20, 2020