Prostate carcinoma prostate cancer
Conditions
Interventions
All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. 
- Arm 1 (Uniform dose) will receive 27 Gray (Gy) in 2 fractions to the whole prostate +/- seminal vesicles (SV) CTV with 0mm PTV margin 
-Arm 2 (De-escalated dose) will use two dose levels. The benign prostate +/- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumor masses (on MRI) will receive 27 Gy
Sponsors
Antoni van Leeuwenhoek (AVL)
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 (ISUP Grade groups (GG) 1, 2 or 3) 4. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry5. The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported). 6. MRI stages mT1 and T2 or mT3a with = 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018). 8. PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT). 9. Patients can be concurrently treated with ADT if this would be standard of care. LHRH analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted.10. WHO Performance status 0-211. Ability of the participant to understand and the willingness to sign a written informed consent (IC) form. 12. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
Exclusion criteria
Exclusion criteria: 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)2. IPSS Score > 19 3. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area. 4. Prostate volume >90cc5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up 6. Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging 7. Previous pelvic radiotherapy 8. Patients needing >6 months 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Emergent acute GU CTCAE Grade 2+ toxicity, recorded within 3 months of completing radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician reported GU and GI toxicity (CTCAE grade) at baseline and the end of treatment then at 2, 4 and 12 weeks post-treatment.Late toxicity (CTCAE) at 1 and 2 years post-treatmentPatient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5 questionnaires. Patients will be asked to complete PROMs at 4 and 12 weeks, 6 months, 1 and 2 years post treatment.PSA control and kinetics at 2 years post-treatment | — |
Countries
Netherlands
Contacts
Public ContactF.J. Pos
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed