Actively Recruiting
Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer
Led by Institute of Cancer Research, United Kingdom · Updated on 2022-06-13
46
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older
- 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
- PSA less than 25 ng/ml before starting androgen deprivation therapy (ADT)
- Concurrent ADT treatment for at least 6 months; up to 12 months considered case-by-case; bicalutamide monotherapy allowed as alternative to LHRH analogues
- World Health Organisation performance status 0 to 2
- Ability to understand and willingness to sign informed consent
- Ability and willingness to complete patient-reported outcome questionnaires throughout the study
You will not qualify if you...
- Contraindications to MRI such as pacemaker, mobile metal implant, or claustrophobia
- International Prostate Symptom Score (IPSS) of 13 or higher
- Post-void residual urine volume greater than 100 mls
- Prostate volume greater than 80 cc
- Comorbidities that increase risk of significant toxicity or prevent long-term follow-up, e.g. inflammatory bowel disease
- Unilateral or bilateral total hip replacement or pelvic metalwork causing imaging artefacts
- Previous pelvic radiotherapy
- Requirement for 2 to 3 years of ADT due to disease parameters
- Previous invasive malignancy within the last 2 years except certain skin cancers, low-risk bladder cancer under surveillance, or small renal masses under surveillance
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Royal Marsden Nhs Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Stephanie Burnett, BSc (Hons)
CONTACT
L
Lorna Bower, BSc (Hons)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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