prostate adenocarcinoma, prostate cancer prostate cancer
Conditions
Interventions
Radiotherapy on the MR-Linac system, two fractions of 12 Gy with a boost on the tumor of 13.5 Gy each time, delivered in eight days.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:Age =18 yearsHistopathological confirmation of prostate adenocarcinoma requiring radical treatmentIntraprostatic tumor visible and delineable on diagnostic imagingEAU intermediate risk prostate cancerGleason score 3+4 and PSA < 10ng/mL and cT1-2* ORGleason score 2-6 and PSA 10-20ng/ml and cT1-2* ORGleason score 3+4 and PSA 10-20ng/mL and cT1-2* ORGleason score 4+3 and cT1-2** based on digital rectal examinationWritten informed consentInformed consent to share medical data and fill out quality of life questionnaires in the MOMENTUM study.
Exclusion criteria
Exclusion criteria: Contraindication to MRIIPSS 15 or higherProstate volume > 80 cciT3a when bulky (tumor size =20 mm), cT3 and iT3bComorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease)Metal pelvic implants which cause artefacts on MR-imaging sequences (e.g., total hip replacement)Previous radical prostatectomyPrevious pelvic radiotherapyPrevious invasive malignancy within the last 5 years, excluding basal cell carcinoma of the skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| difference in proportion of participants with acute (within 12 weeks after start radiotherapy) CTCAE grade 2 or higher acute genitourinary toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess physician reported toxicity (CTCAE) other than acute GU toxicityTo assess patient reported outcome measures (PROMs), using the following validated instruments:EORTC-QLQ-C30 (general quality of life for patients who undergo/underwent oncological treatment)IPSS (urinary symptoms)EQ-5D (cost-effectiveness and general QoL)EORTC-QLQ-PR25 (prostate-related quality of life after oncological therapy)To assess biochemical progression free survival and time to relapse, through evaluation of PSA control and kinetics. | — |
Countries
Netherlands
Contacts
Public ContactJ.R.N. Voort Van Zyp
Universitair Medisch Centrum Utrecht
Outcome results
None listed