Last updated: April 18, 2024
Sponsor: Royal Marsden NHS Foundation Trust
Overall Status: Active - Recruiting
Phase
N/A
Condition
Prostate Cancer
Adenocarcinoma
Treatment
De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac
Clinical Study ID
NCT05709496
CCR5715
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Men aged ≥18 years
- Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
- MRI stage T2 or less (as staged by AJCC TNM 2018)
- MRI-visible tumour(s) of Prostate Imaging-Reporting and Data System (PIRADS) v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhancedimaging with concordant pathology
- Tumour nodule visible on MRI occupying <50% of prostate on any axial slice and <50%total prostate volume
- PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT)
- Patients can be concurrently treated with androgen deprivation therapy if this wouldbe standard of care. Luteinizing hormone-releasing hormone (LHRH) analogues orBicalutamide are permitted. ADT is not mandatory where this would usually be omitted.
- World Health Organisation (WHO) Performance status 0-2
- Ability of the participant understand and the willingness to sign a written informedconsent form.
- Ability/willingness to comply with the patient reported outcome questionnairesschedule throughout the study.
Exclusion
Exclusion Criteria:
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant,claustrophobia)
- IPSS 19 or higher
- High grade disease (GG3) occult to MRI-defined lesion
- Post-void residual >100 mls, where known
- Prostate volume >90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory boweldisease) or preclude long term follow up
- Unilateral or bilateral total hip replacement, or other pelvic metalwork which causesartefact on diffusion-weighted imaging
- Previous pelvic radiotherapy
- Patients needing >6 months of ADT due to disease parameters.
- Previous invasive malignancy within the last 2 years excluding basal or squamous cellcarcinomas of the skin, low risk non-muscle invasive bladder
Study Design
Total Participants: 20
Treatment Group(s): 1
Primary Treatment: De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
March 01, 2027
Study Description
Connect with a study center
The Royal Marsden Hospital
Sutton, Surrey SM2 5PT
United KingdomActive - Recruiting

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