Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer
NCT ID: NCT04595019
Last Updated: 2022-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2021-07-29
2028-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5 fraction
MRI-guided radiotherapy, 36.25 Gray (Gy) in 5 fractions (boost to 40 Gy over tumour/prostate CTV) over 10 days.
SBRT
Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.
2 fraction
MRI-guided radiotherapy, 24 Gy in 2 fractions (boost to 27 Gy over tumour/prostate CTV) over 8 days.
SBRT
Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.
Interventions
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SBRT
Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Alison Tree, BSc, MBBS, FRCR,
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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The Royal Marsden Nhs Foundation Trust
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCR5273
Identifier Type: OTHER
Identifier Source: secondary_id
285291
Identifier Type: OTHER
Identifier Source: secondary_id
ICR-CTSU/2020/10070
Identifier Type: -
Identifier Source: org_study_id
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