Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
HERMES is a single-centre, randomized phase II trial which recruits men with intermediate or lower high risk localised prostate cancer to one of two radiotherapy prescriptions
men either receive five-fraction stereotactic body radiotherapy (SBRT) over 10 days or two-fraction SBRT over 8 days.
Adult patients with newly diagnosed intermediate or lower high risk localised pro
a radiotherapy CT (computerised tomography) and an MRI (Magnetic Resonance Imaging) planning scan. The radiotherapy CT is part of standard of care. The MRI scans are standard for SBRT patients but are
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: All participants will be recruited at The Royal Marsden Hospital in the UK. Eligible men will be identified in oncology clinics and discussed at Multi-Disciplinary Team (MDT) meetings at The Royal Marsden. 1. Men aged =18 years 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 (as staged by AJCC TNM 2018) 5. PSA < 25 ng/ml prior to starting ADT 6. Patients will be concurrently treated with androgen deprivation therapy 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 analogues if required 7. WHO 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
Exclusion criteria: 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia) 2. IPSS 13 or higher 3. Post-void residual > 100 ml 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 except 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. 10. Patients will all be concurrently treated with Androgen deprivation therapy for at least 6 months, as per standard of care. Men who need longer courses of ADT may be considered on a case by case basis, and bicalutamide monotherapy is accepted as an alternative to LHRH analogues if required. Men who do not need/are not able to have hormone therapy are also included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with CTCAE Grade 2+ genitourinary (GU) toxicity at any point from the start of radiotherapy to 12 weeks post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: 1. Physician-reported CTCAE GU and GI toxicity reported during treatment and at 12 weeks post-treatment will be summarised according to grade and treatment received using descriptive statistics at each timepoint 2. 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 timepoint 3. 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. 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. Change from baseline measured at 12 weeks, 1, 2 and 5 years post-treatment 4. Time to event: PSA (Prostate-Specific Antigen) control and biochemical failure/progression measured at 2 and 5 years Exploratory outcome measure: 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 | — |
Countries
England, United Kingdom
Outcome results
None listed