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ACTIVE NOT RECRUITING
NCT05917860
PHASE1

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

Sponsor: Turku University Hospital

View on ClinicalTrials.gov

Summary

Clinical studies have shown that magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) of the prostate is safe and effective. In the TULSA procedure, prostate tissue is killed by heating with ultrasound. This clinical trial explores if adding drug therapy with Degarelix before TULSA has the potential to improve further the effectiveness of TULSA in the treatment of localized prostate cancer, especially for patients with more aggressive diseases.

Official title: Effect of Neoadjuvant Degarelix on MRI-guided Transurethral Ultrasound Ablation (TULSA) in Patients with Intermediate-risk Prostate Cancer: a Pilot Study

Key Details

Gender

MALE

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-07-18

Completion Date

2030-01-31

Last Updated

2025-02-17

Healthy Volunteers

No

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.

Locations (1)

Turku University Hospital

Turku, Southwest Finland, Finland