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| ID | Type | Description | Link |
|---|---|---|---|
| CCR5273 | Other Identifier | Sponsor code | |
| 285291 | Other Identifier | IRAS ID |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Genitourinary (GU) toxicity | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) toxicity | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess bi-parametric MRI prostate imaging parameters during treatment | Descriptive statistics will be used to report and analyse the change in ADC (Apparent diffusion coefficient) between baseline and 4 weeks and between baseline and 12 weeks. | 4 and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Burnett, BSc (Hons) | Contact | 02087224261 | hermes@icr.ac.uk | |
| Lorna Bower, BSc (Hons) | Contact | 020 8661 3561 | 1119 | hermes@icr.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Alison Tree, BSc, MBBS, FRCR, | Royal Marsden NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden Nhs Foundation Trust | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Single centre, randomised phase II trial
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| Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) late toxicity |
Late toxicity (CTCAE) at 1, 2 and 5 years post-treatment will be summarised according to grade and treatment received at each time point. |
| 1, 2 and 5 years |
| Quality of life patient-reported outcomes | 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. | 12 weeks, 1, 2 and 5 years post treatment. |
| PSA (Prostate Specific Antigen) control and biochemical failure/progression | Time to event. | 2 and 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |