Neoadjuvant ADT with TULSA in the Treatment of Intermediate Risk Prostate Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 18, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2030

Conditions
Localized Prostate CarcinomaCastration-Naive Prostate CancerIntermediate Risk Prostate CancerProstate Cancer
Interventions
DRUG

Degarelix

Degarelix is injected subcutaneously into the fatty tissue of the abdomen. A typical protocol consists of a starting dose of 240 mg with a maintenance dose of 80 mg administered every 28 days. In this study, one starting dose and two maintenance doses of Degarelix will be administered between baseline and TULSA treatment in accordance with the terms of Degarelix marketing authorizations.

DEVICE

MRI-guided transurethral ultrasound ablation (TULSA)

MRI-guided transurethral ultrasound ablation (TULSA) (TULSA-PRO, Profound Medical Inc., Toronto, Canada) will be used to deliver whole-prostate gland treatment in accordance with the terms of TULSA marketing authorizations. The treating physicians will contour the entire prostate gland for a whole gland ablation.

Trial Locations (1)

20521

Turku University Hospital, Turku

All Listed Sponsors
lead

Turku University Hospital

OTHER_GOV