prostate cancer prostate carcinoma
Conditions
Interventions
Radiotherapy
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men aged >=18 years 2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy 3. Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3) 4. MRI stage T2 or less (as staged by AJCC TNM 2018) 5. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology 6. Dominant lesion
Exclusion criteria
Exclusion criteria: 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia) 2. IPSS 19 or higher 3. biopsies >=GG3 occult to MRI-defined lesion 4. Post-void residual >100 mls, where known 5. Prostate volume >90cc 6. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up 7. Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging 8. Previous pelvic radiotherapy 9. Patients needing >6 months of ADT due to disease parameters. 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an MR-linac. Feasibility is defined as coverage of GTV boost D90% >42Gy on the post-treatment MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Physician reported GU and gastrointestinal (GI) toxicity (CTCAE grade) at baseline and the end of treatment then at 4 weeks and 3 months post-treatment. • Late toxicity (CTCAE) at 1 and 2 years post-treatment • Patient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5 questionnaires. Patients will be asked to complete PROMs at 4 weeks, 3 and 6 months, 1 and 2 years post treatment. • PSA control and kinetics at 2 years post-treatment | — |
Countries
Netherlands
Outcome results
None listed