At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- SBRT (radiation)
- How long the study runs
- Study runs about 81 months (dates as stated)
- About the drug or intervention
- SBRT — radiation: Stereotactic Body Radiotherapy.
- Patient visit burden
- Not specified by the sponsor
In plain English
This UK study, run by the Institute of Cancer Research, is looking at a shorter, faster course of radiotherapy (hypofractionated expedited radiotherapy) for men with localised prostate cancer. It aims to treat men whose cancer has not spread beyond the prostate area.
Who can take part
- Men aged 18 or over
- Prostate cancer confirmed by tissue tests (biopsy) that needs radiotherapy treatment aiming to cure
- Gleason score of 3+4 or 4+3 (grade groups 2 or 3)
- Cancer visible on an MRI scan as stage T3a or less (not spread far)
- PSA (prostate-specific antigen, a blood marker) level under 25 ng/ml before starting hormone therapy
- Having hormone therapy (androgen deprivation therapy, ADT) for at least 6 months alongside radiotherapy; up to 12 months may be allowed, and a tablet called bicalutamide can be used instead of other hormone injections if needed
- Able to carry out day-to-day activities at least half the time (World Health Organisation performance status 0 to 2)
- Able to understand and sign a consent form, and willing to fill in patient questionnaires during the study
Who may not be able to
- Unable to have an MRI scan (for example because of a pacemaker, certain metal implants, or severe claustrophobia)
- An International Prostate Symptom Score (a urinary symptom questionnaire) of 13 or higher
- More than 100 ml of urine left in the bladder after passing water
- A prostate larger than 80 cc
- Other health conditions that could cause serious side effects (such as inflammatory bowel disease) or make long-term follow-up impossible
- A hip replacement on one or both sides, or other metal implants in the pelvis that blur the MRI pictures
- Previous radiotherapy to the pelvis
- Needing 2 to 3 years of hormone therapy because of the cancer's features
- Another invasive cancer in the past 2 years (with some exceptions, such as some skin cancers, some low-risk bladder cancers, and small kidney lumps being monitored)
What taking part involves
- • A shorter, faster course of radiotherapy than usual (hypofractionated expedited radiotherapy)
- • Hormone therapy (ADT) for at least 6 months, given as injections or as a tablet called bicalutamide
Time commitment: Length of the trial and number of hospital visits: Not stated — ask the trial team. Taking part involves radiotherapy, at least 6 months of hormone therapy, and filling in questionnaires throughout the study.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 46
- Started
- 2021-07-29
- Last checked
- 2022-06
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • NA - 46 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Sutton - The Royal Marsden Nhs Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
What the study is looking for
- ✓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
- ✓PSA \<25 ng/ml prior to starting ADT (Androgen deprivation therapy)
Who cannot take part
- ✗Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- ✗International Prostate Symptom Score (IPSS) 13 or higher
- ✗Post-void residual \>100 mls
- ✗Prostate volume \>80cc
- ✗other health conditions which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
See the full criteria
Where Is This Study? (1 UK site)
The Royal Marsden Nhs Foundation Trust
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Stephanie Burnett, BSc (Hons)
Sponsor contactCONTACT
Lorna Bower, BSc (Hons)
Sponsor contactCONTACT