NCT05917860

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Androgen deprivation therapy (ADT) has been shown to reduce prostate and tumor size. In this study, magnetic resonance imaging (MRI) is used to investigate the effect of Degarelix ADT on the properties of prostate tissue that can affect the heating of the tissues in the TULSA procedure. The main goal is to find out if ADT can change the tissue structure in a way that improves the ability of the TULSA procedure to heat tissues and better kill the diseased tissue, reducing the chance of the disease reoccurring. ADT and the TULSA procedure can help patients with more aggressive diseases avoid the adverse effects associated with surgery or radiation therapy. Specific objectives are: 1. To measure the change in prostate and tumor size, tissue structural changes, and the blood flow within the prostate after ADT. 2. To measure the distribution of heating over the prostate after TULSA treatment. 3. To evaluate complications and genitourinary function and quality of life with patient-reported outcome measures. 4. To evaluate local cancer control and longer-term oncological outcomes after combination therapy of neoadjuvant ADT and TULSA treatment. About 15 subjects will participate. Each will receive Degarelix for three months, followed by whole-prostate gland TULSA treatment, and be followed for five years. Throughout the study, subjects will receive MRI scans and complete questionnaires regarding functional status and quality of life to understand the side effects.

Conditions

• Localized Prostate Carcinoma
• Castration-Naive Prostate Cancer
• Intermediate Risk Prostate Cancer
• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-18
• Primary completion: 2026-01-31
• Completion: 2030-01-31
• First posted: 2023-06-26
• Last updated: 2025-02-17

Locations

1 site across 1 country: Finland