Prostate carcinoma
Conditions
Interventions
1. After the patient has signed for informed consent, a baseline visit (V1)
will be scheduled with the urologist and a clinical PhD student. At this visit,
questions about the trial will be answered
the patient will be asked to complete some questionnaires (EPIC-26,
EORTC QLQ-PR25 scale for sexual symptoms, ICIQ, IPSS, SHIM IIEF-5, and EuroQol
5D).
2. Randomization. The patient*s urologist (an
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men with unilateral clinically significant intermediate-risk PCa ór dominant unilateral clinically significant intermediate-risk and small contralateral low-risk (ISUP 1) disease: • Gleason score of 7 (3 + 4 or 4 + 3; ISUP grade 2/3) • PSA level of = 10 years • Men with a prostate size
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Unfit for general anesthesia or radical surgery • Low volume low-risk disease (= 8 / ISUP grade >3) • Clinical T3 disease (extracapsular PCa) • Men who have received previous active therapy for PCa. • Men with evidence of extraprostatic disease. • Men with an inability to tolerate a transrectal ultrasound. • Cardiac pacemaker • Metal implants/stents in the urethra or prostate. • ASA >=4 • Prostatic calcification/cysts that interfere with effective delivery of TULSA/HIFU based on CT. • Men with renal impairment and a glomerular filtration rate (GFR) of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint • Oncological effectiveness (non-inferiority), defined as treatment failure, i.e. the need for retreatment with salvage treatment (RP or RT) in the focal therapy group and as biochemical recurrence followed by salvage treatment in the usual care group. Follow-up will be for at least 48 months so that more data on (metastasis-free) survival can be collected for oncological effectiveness • Quality of life (superiority), measured with EPIC-26 questionnaires at 12 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints (if applicable) • Metastasis-free survival (validated surrogate endpoint of overall survival) • Generic health-related quality of life at baseline, 3, 6, 12, 24, 36, 48 and 60 months using validated questionnaires (EPIC-26, EORTC QLQ-PR25 for sexual symptoms, ICIQ, IPSS, SHIM IIEF-5, EuroQoL 5D) • Oncologic safety • Disease progression • Disease-specific mortality • All-cause mortality • Operating time • Hospital care stay • Pathology results • Adverse events • Cost-effectiveness | — |
Countries
Netherlands
Contacts
Public ContactL.P.W. te Molder
Radboud Universitair Medisch Centrum
Outcome results
None listed