Active — Not RecruitingPhase 1

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

Finland15 participantsStarted 2023-07-18

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * ISUP GG 2 or 3 * Biopsy obtained ≥ 6 weeks and ≤ 12 months before treatment * PSA ≤ 20 ng/ml * No prior definitive treatment of prostate cancer * Eligible for MRI * Eligible for general anesthesia (American Society of Anesthesiologists Class III or less) * Patients taking 5-alpha reductase inhibitors (5-ARIs) are eligible if use is discontinued three months before and throughout the study period. * Informed consent: The patient must speak Finnish, English, or Swedish and must be able to understand the meaning of the study. The patient must be willing and able to sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff. Exclusion Criteria: * 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 infarcti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in prostate volume after neoadjuvant ADT

Timeframe: Baseline and four, eight, and 12 weeks of ADT.

Change in prostate tumor volume after neoadjuvant ADT

Timeframe: Baseline and four, eight, and 12 weeks of ADT.

The frequency and severity of adverse events

Timeframe: Every follow-up visit until the first year of follow-up.

Trial details

NCT IDNCT05917860

SponsorTurku University Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Localized Prostate Carcinoma trials

Plain-language summary

Who can participate

Age range

40 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in prostate volume after neoadjuvant ADT

Timeframe: Baseline and four, eight, and 12 weeks of ADT.

Change in prostate tumor volume after neoadjuvant ADT

Timeframe: Baseline and four, eight, and 12 weeks of ADT.

The frequency and severity of adverse events

Timeframe: Every follow-up visit until the first year of follow-up.