Stereotactic Body Radiotherapy for Prostate Cancer
Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer
Recruiting
N/AInterventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
Institute of Cancer Research, United Kingdom · Other
Who this trial is looking for
This trial is looking for men with localized prostate cancer to compare two different treatment schedules using precise X-ray therapy. Participants will receive either five treatments over ten days or two larger treatments in eight days.
Are You a Good Fit for This Trial?
Must be takingAndrogen deprivation therapy
You may be able to join if
I am a man aged 18 or older.
I have been diagnosed with prostate cancer that needs radical treatment.
I have a Gleason score of 3+4 or 4+3.
My cancer is at stage T3a or less.
My PSA level is less than 25 ng/ml before starting hormone therapy.
I will receive hormone therapy for at least six months.
I have a good performance status (WHO 0-2).
I can understand and agree to sign a consent form.
You may not be able to join if
I cannot have an MRI for any reason.
My prostate symptoms are severe (IPSS score of 13 or higher).
I have more than 100 mls of urine left in my bladder after I urinate.
My prostate volume is over 80cc.
I have health issues that may cause significant side effects.
I have metal implants that affect MRI imaging.
I have had radiation therapy in my pelvis before.
I have had another invasive cancer in the last two years, except for some skin cancers.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 exa…
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 Locations
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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 conc…
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.
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