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

What Was Tested

This registered phase 1 trial tested Degarelix.

In the TULSA procedure, prostate tissue is killed by heating with ultrasound.

It had 1 arm (groups): 3-month neoadjuvant Degarelix followed by whole-gland MRI-guided transurethral ultrasound ablation (experimental).

The registry classes the interventions as device and drug.

More on the Plan

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.

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.

Who Took Part

Enrollment: 15 planned participants were the target.

It was open to men only aged from 40 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male age ≥ 40 years and candidate for radical prostate cancer treatment. Estimated life expectancy \> 8 years. At least one MRI-visible and biopsy-concordant tumor defined as Prostate Imaging-Reporting and Data System v2 (PI-RADS v2.1) ≥ 3. Biopsy-confirmed, intermediate-risk localized prostate cancer:. Clinical or radiological tumor stage ≤ T2c, N0, M0.

The full record lists 13 inclusion and 14 exclusion criteria; among the exclusions: prior prostate cancer treatment with chemotherapy or hormonal therapy, including chemical or surgical castration, antiandrogen therapy, or androgen-receptor signaling inhibitors; relative or absolute contraindication to degarelix; severe, active cardiovascular comorbidity including unstable angina pectoris, congestive heart failure, deep vein thrombosis, pulmonary embolism, or myocardial infarction within the last six months.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-07-18 with completion listed for 2026-01-31.

It ran at 1 site in Finland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in prostate volume after neoadjuvant ADT (time frame: Baseline and four, eight, and 12 weeks of ADT). Change in prostate tumor volume after neoadjuvant ADT (time frame: Baseline and four, eight, and 12 weeks of ADT). The frequency and severity of adverse events (time frame: Every follow-up visit until the first year of follow-up).

It also tracked 19 secondary outcomes, for example Change in prostate tumor-capsule contact length after neoadjuvant ADT, Change in prostate vascular perfusion after neoadjuvant ADT, Change in prostate tumor vascular perfusion after neoadjuvant ADT, Change in periprostatic, prostate and tumor tissue structures after neoadjuvant ADT, Thermal coverage after whole-prostate gland TULSA and Change in quality of life (QoL) and functional status outcomes after neoadjuvant ADT.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Degarelix in 15 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Degarelix compound page, all human trials.