Erectile dysfunction, localized prostate cancer, MR-guided radiotherapy (MRgRT) Impotence, prostate cancer, radiation-induced side effects
Conditions
Interventions
All patients will receive MR-Linac treatment consisting of 5 fractions of 7.25
Gy with neurovascular sparing (i.e. additional sparing of the neurovascular
bundles, internal pudendal arteries, penile
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >= 18 years • Histologically proven adenocarcinoma of the prostate • Low-risk or intermediate-risk prostate cancer according to NCCN risk categories (low risk: T1c-T2a, Gleason score
Exclusion criteria
Exclusion criteria: Use of (neo-)adjuvant androgen deprivation therapy • High-risk prostate cancer according to NCCN risk categories (T3a or Gleason score 8-10 or PSA >20 µg/L) • Patients with *bulky* iT3 tumor diagnosis • Previous pelvic irradiation or radical prostatectomy • Clinical evidence of metastatic disease • Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht (see appendix I) • Patients who are incompetent to sign written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: the incidence of erectile dysfunction (ED) three years after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: erectile dysfunction (at 6, 12 and 24 months), relapse-free survival, acute and late urogenital and gastrointestinal toxicity, and patient-reported quality of life. | — |
Countries
Netherlands
Contacts
Public ContactJ.R.N. Voort van Zyp
Universitair Medisch Centrum Utrecht
Outcome results
None listed