Localized Prostate CarcinomaPhase 1NeoADT-TULSANCT05917860

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

A Phase 1 study testing Degarelix and MRI-guided transurethral ultrasound ablation (TULSA) in people with Localized Prostate Carcinoma and Castration-Naive Prostate Cancer, run by Turku University Hospital at 1 site in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years, men only
Conditions the study is for: Localized Prostate Carcinoma, Castration-Naive Prostate Cancer, Intermediate Risk Prostate Cancer
What is being tested?: Degarelix and MRI-guided transurethral ultrasound ablation (TULSA)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteFinland
Study dates: 18 Jul 2023to 31 Jan 2030
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to 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
ISUP GG 2 or 3

Show all 13Show fewer

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.

Who cannot join

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.
Inability to undergo MRI due to claustrophobia or contraindications (cardiac pacemaker, intracranial clips, etc.)
Severe kidney failure as determined by estimated glomerular filtration rate (eGFR) less than 30 ml/min per 1.73 m2
Prostate calcifications obstructing the planned ultrasound beam path in the line of sight of the MRI visible tumor

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Prostate cysts at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumor
Evidence of extraprostatic disease based on imaging (MRI, bone scintigraphy, single-photon emission tomography, computed tomography, prostate-specific membrane antigen-positron emission tomography [PSMA-PET]) or histopathology
History of chronic inflammatory conditions (e.g., inflammatory bowel disease) affecting the rectum (also includes rectal fistula and anal/rectal stenosis)
Hip replacement surgery or other metal in the pelvic area
Known allergy or contraindication to gadolinium or gastro-intestinal anti-spasmodic drug glucagon
Concomitant treatment with medications contraindicated to Glucagen used as antispasmolytic agent during TULSA treatment (e.g., Feochromocytoma)
Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist
Another primary malignancy unless disease-free survival is > 8 years

Trial locations and contacts

1 site in 1 country.

Finland1 site

Turku University Hospital
Turku, Southwest Finland, 20521

Other trials in Finland

About this study

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

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.

Read the 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:

To measure the change in prostate and tumor size, tissue structural changes, and the blood flow within the prostate after ADT.
To measure the distribution of heating over the prostate after TULSA treatment.
To evaluate complications and genitourinary function and quality of life with patient-reported outcome measures.
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
Being tested: Degarelix, MRI-guided transurethral ultrasound ablation (TULSA)
Keywords: MRI-guided transurethral ultrasound ablation, Androgen deprivation therapy, Neoadjuvant androgen deprivation therapy, TULSA, Prostate cancer, Thermal ablation, Therapeutic ultrasound, Ablation therapy
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DegarelixDrug
Also called Firmagon
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.
MRI-guided transurethral ultrasound ablation (TULSA)Device
Also called TULSA-PRO
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.

Study groups in NCT05917860
Study group	Role	What they receive
3-month neoadjuvant Degarelix followed by whole-gland MRI-guided transurethral ultrasound ablation	Experimental	After three months of neoadjuvant ADT with Degarelix, the subject will undergo whole-prostate gland MRI-guided transurethral ultrasound ablation (TULSA) (TULSA-PRO, Profound Medical Inc., Toronto, Canada) treatment. Receives: Drug: Degarelix; Device: MRI-guided transurethral ultrasound ablation (TULSA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in prostate volume after neoadjuvant ADT
The prostate volume change will be determined by comparing the prostate volume measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.
Measured: Baseline and four, eight, and 12 weeks of ADT.
Change in prostate tumor volume after neoadjuvant ADT
The prostate tumor volume change will be determined by comparing the prostate tumor volume measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.
Measured: Baseline and four, eight, and 12 weeks of ADT.
The frequency and severity of adverse events
The frequency and severity of adverse events after neoadjuvant Degarelix and TULSA treatment will be determined by using the CTCAE v6.0 classification. Adverse events attributed to TULSA will also be graded using the Clavien Dindo classification for surgical complications.
Measured: Every follow-up visit until the first year of follow-up.

Secondary outcomes (19)

Change in prostate tumor-capsule contact length after neoadjuvant ADT
The prostate tumor-capsule contact length change will be determined by comparing the prostate tumor-capsule contact length measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.
Measured: Baseline and four, eight, and 12 weeks of ADT.
Change in prostate vascular perfusion after neoadjuvant ADT
The change in prostate vascular perfusion will be determined by comparing average blood flow values in the prostate measured on dynamic contrast-enhanced T1-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.
Measured: Baseline and four, eight, and 12 weeks of ADT.
Change in prostate tumor vascular perfusion after neoadjuvant ADT
The change in prostate tumor vascular perfusion will be determined by comparing average blood flow values in the prostate tumor measured on dynamic contrast-enhanced T1-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.
Measured: Baseline and four, eight, and 12 weeks of ADT.
Change in periprostatic, prostate and tumor tissue structures after neoadjuvant ADT
The change in periprostatic, prostate and tumor tissue structures will be determined by comparing the radiomics features extracted from T2-weighted, T2 relaxation time mapping, and diffusion-weighted images at four, eight, and 12 weeks of ADT to that at baseline.
Measured: Baseline and four, eight, and 12 weeks of ADT.
Thermal coverage after whole-prostate gland TULSA
Thermal coverage of the target volume achieved by whole-prostate gland TULSA will be determined by comparing physician-defined target boundaries to MRI measurements of temperature distributions, thermal dose distributions, and acute treatment-induced perfusion defect immediately post-treatment.
Measured: Immediately after the TULSA procedure.
Change in quality of life (QoL) and functional status outcomes after neoadjuvant ADT
The change in QoL and functional status outcomes will be determined by comparing the summary scores of urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains of the Expanded Prostate Index Composite-26 (EPIC-26) questionnaire at 12 weeks of ADT to that at baseline. EPIC-26 contains 26 items with response options for each EPIC item forming a Likert Scale, and multi-item scale scores transformed linearly to a 0-100 scale, with higher scores representing better functional status/QoL.
Measured: Baseline and 12 weeks of ADT.
Change in lower urinary tract symptoms after neoadjuvant ADT
The change in lower urinary tract symptoms will be determined by comparing the International Prostate Symptom Score (IPSS) at 12 weeks of ADT to that at baseline. The possible scores for the IPSS questionnaire range from 0 to 35, with higher scores representing worse symptoms.
Measured: Baseline and 12 weeks of ADT.
Change in erectile function after neoadjuvant ADT
The change in erectile function will be determined by comparing the International Index of Erectile Function (IIEF-5) score at 12 weeks of ADT to that at baseline. The possible scores for the IIEF-5 range from 5 to 25, with higher scores representing a better erectile function.
Measured: Baseline and 12 weeks of ADT.
Change in quality of life (QoL) and functional status outcomes after neoadjuvant ADT and whole-prostate gland TULSA
The change in QoL and functional status outcomes will be determined by comparing the summary scores of urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains of the Expanded Prostate Index Composite (EPIC-26) questionnaire at three, six, 12, 36 and 60 months post-TULSA to that at baseline and TULSA procedure. EPIC-26 contains 26 items with response options for each EPIC item forming a Likert Scale, and multi-item scale scores transformed linearly to a 0-100 scale, with higher scores representing better functional status/QoL.
Measured: Baseline and 12 weeks of ADT, and three, six, 12, 36 and 60 months after the TULSA procedure.
Change in lower urinary tract symptoms after neoadjuvant ADT and whole-prostate gland TULSA
The change in lower urinary tract symptoms will be determined by comparing the International Prostate Symptom Score (IPSS) at three, six, 12, 36 and 60 months post-TULSA to that at baseline and TULSA procedure. The possible scores for the IPSS questionnaire range from 0 to 35, with higher scores representing worse symptoms.
Measured: Baseline and 12 weeks of ADT, and three, six, 12, 36 and 60 months after the TULSA procedure.
Change in erectile function after neoadjuvant ADT and whole-prostate gland TULSA
The change in erectile function will be determined by comparing the International Index of Erectile Function (IIEF-5) score at three, six, 12, 36 and 60 months post-TULSA to that at baseline and TULSA procedure. The possible scores for the IIEF-5 range from 5 to 25, with higher scores representing a better erectile function.
Measured: Baseline and 12 weeks of ADT, and three, six, 12, 36 and 60 months after the TULSA procedure.
The frequency and severity of adverse events during extended follow-up
The frequency and severity of adverse events after neoadjuvant Degarelix and TULSA treatment will be determined using the CTCAE v6.0 classification. Adverse events attributed to TULSA will also be graded using the Clavien Dindo classification for surgical complications.
Measured: Every follow-up visit until the five years of follow-up.
Salvage therapy-free survival
Salvage therapy-free survival will be defined as freedom from radical salvage treatments for prostate cancer including radical prostatectomy, radiotherapy, or ablation, and reported as the proportion of subjects who have not reached those events.
Measured: Every post-TULSA follow-up visit until the five years of follow-up.
Systemic therapy-free survival
Systemic therapy-free survival will be defined as freedom from additional systemic therapy including but not limited to additional ADT or chemotherapy for the treatment of prostate cancer, and reported as the proportion of subjects who have not reached those events.
Measured: Every post-TULSA follow-up visit until the five years of follow-up.
Failure-free survival
Failure-free survival will be defined as freedom from salvage treatment, systemic treatment, metastases, or death from prostate cancer, and reported as the proportion of subjects who have not reached those events.
Measured: Every post-TULSA follow-up visit until the five years of follow-up.
Metastasis-free, prostate cancer-specific, and overall survival
Metastasis-free, prostate cancer-specific and overall survivals will be assessed one, three, and five years after TULSA and reported as the proportion of subjects who have not reached those endpoints.
Measured: One, three and five years after the TULSA procedure.
Biochemical failure-free survival
PSA at each timepoint, as well as PSA nadir, will be reported. The proportion of subjects with biochemical failure, defined as a PSA value more than 2.0 ng/ml above nadir, will be reported.
Measured: One, three, and five years after the TULSA procedure.
Freedom from biopsy-proven clinically-significant prostate cancer
Histopathologic verification of treatment response to TULSA treatment will be confirmed at 12 months post-TULSA with targeted plus 10-12-core systematic biopsy. The proportion of subjects with a clinically-significant disease, defined as Gleason grade ≥ 3 + 4 and ISUP (International Society of Urological Pathology) grade group ≥ 2 prostate cancer, on biopsy, will be reported.
Measured: Twelve months after the TULSA procedure
Freedom from any biopsy-proven prostate cancer
Histopathologic verification of treatment response to TULSA treatment will be confirmed at 12 months post-TULSA with targeted plus 10-12-core systematic biopsy. The number, location, grade, and percent of cancer involvement within each core will be collected. The proportion of subjects with any prostate cancer on biopsy, will be reported.
Measured: Twelve months after the TULSA procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 202331 Jan 2030

First posted26 Jun 2023
Study start18 Jul 2023
Primary completion31 Jan 2026
Study completion31 Jan 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Localized Prostate CarcinomaStudies of the same condition, open and under way.
More trials run by Turku University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Procedure: Magnetic resonance imaging-guided transurethral ultrasound ablation of the prostate (TULSA) Drug: Degarelix
Masking: None (open label)
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05917860
Sponsor's protocol ID: T1338/2023
Acronym: NeoADT-TULSA
Status last verified: Oct 2026
First submitted: 2 May 2023
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Anttinen M, Blanco Sequeiros R, Bostrom PJ, Taimen P. Evolving imaging methods of prostate cancer and the emergence of magnetic resonance imaging guided ablation techniques. Front Oncol. 2022 Nov 17;12:1043688. doi: 10.3389/fonc.2022.1043688. eCollection 2022.
PubMed 36465377
Valerio M, Cerantola Y, Eggener SE, Lepor H, Polascik TJ, Villers A, Emberton M. New and Established Technology in Focal Ablation of the Prostate: A Systematic Review. Eur Urol. 2017 Jan;71(1):17-34. doi: 10.1016/j.eururo.2016.08.044. Epub 2016 Aug 29.
PubMed 27595377
Klotz L, Pavlovich CP, Chin J, Hatiboglu G, Koch M, Penson D, Raman S, Oto A, Futterer J, Serrallach M, Relle J, Lotan Y, Heidenreich A, Bonekamp D, Haider M, Tirkes T, Arora S, Macura KJ, Costa DN, Persigehl T, Pantuck AJ, Bomers J, Burtnyk M, Staruch R, Eggener S. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer. J Urol. 2021 Mar;205(3):769-779. doi: 10.1097/JU.0000000000001362. Epub 2020 Oct 6.
PubMed 33021440
EAU Guidelines 2023, presented at the EAU Annual Congress Milan 2023. ISBN 978-94-92671-16-5.
Denham JW, Steigler A, Lamb DS, Joseph D, Turner S, Matthews J, Atkinson C, North J, Christie D, Spry NA, Tai KH, Wynne C, D'Este C. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol. 2011 May;12(5):451-9. doi: 10.1016/S1470-2045(11)70063-8.
PubMed 21440505
Hu J, Xu H, Zhu W, Wu F, Wang J, Ding Q, Jiang H. Neo-adjuvant hormone therapy for non-metastatic prostate cancer: a systematic review and meta-analysis of 5,194 patients. World J Surg Oncol. 2015 Feb 22;13:73. doi: 10.1186/s12957-015-0503-z.
PubMed 25884478
Nishiyama T. Serum testosterone levels after medical or surgical androgen deprivation: a comprehensive review of the literature. Urol Oncol. 2014 Jan;32(1):38.e17-28. doi: 10.1016/j.urolonc.2013.03.007. Epub 2013 Jun 13.
PubMed 23769268
Christie DRH, Mitina N, Sharpley CF. A prospective study of the effect of testosterone escape on preradiotherapy prostate-specific antigen kinetics in prostate cancer patients undergoing neoadjuvant androgen deprivation therapy. Curr Urol. 2021 Mar;15(1):63-67. doi: 10.1097/CU9.0000000000000008. Epub 2021 Mar 29.
PubMed 34084124
Klotz LH, Goldenberg SL, Jewett MA, Fradet Y, Nam R, Barkin J, Chin J, Chatterjee S; Canadian Uro-Oncology Group. Long-term followup of a randomized trial of 0 versus 3 months of neoadjuvant androgen ablation before radical prostatectomy. J Urol. 2003 Sep;170(3):791-4. doi: 10.1097/01.ju.0000081404.98273.fd.
PubMed 12913699
Kumar S, Shelley M, Harrison C, Coles B, Wilt TJ, Mason MD. Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006019. doi: 10.1002/14651858.CD006019.pub2.
PubMed 17054269
Sumitomo M, Hayashi M, Watanabe T, Tsugawa M, Noma H, Yamaguchi A, Nagakura K, Hayakawa M, Uchida T. Efficacy of short-term androgen deprivation with high-intensity focused ultrasound in the treatment of prostate cancer in Japan. Urology. 2008 Dec;72(6):1335-40. doi: 10.1016/j.urology.2007.12.041. Epub 2008 Mar 20.
PubMed 18355899
Aoyagi, Teiichiro, and Isao Kuroda. Enhancement of HIFU Effect by Simultaneous Short Course Degarelix for Early Stage Prostate Cancer: A Pilot Study. Open Journal of Urology 6.03 (2016): 49-54.
Crawford ED, Shore ND, Moul JW, Tombal B, Schroder FH, Miller K, Boccon-Gibod L, Malmberg A, Olesen TK, Persson BE, Klotz L. Long-term tolerability and efficacy of degarelix: 5-year results from a phase III extension trial with a 1-arm crossover from leuprolide to degarelix. Urology. 2014 May;83(5):1122-8. doi: 10.1016/j.urology.2014.01.013. Epub 2014 Mar 22.
PubMed 24661333
Anttinen M, Makela P, Viitala A, Nurminen P, Suomi V, Sainio T, Saunavaara J, Taimen P, Sequeiros RB, Bostrom PJ. Salvage Magnetic Resonance Imaging-guided Transurethral Ultrasound Ablation for Localized Radiorecurrent Prostate Cancer: 12-Month Functional and Oncological Results. Eur Urol Open Sci. 2020 Nov 25;22:79-87. doi: 10.1016/j.euros.2020.10.007. eCollection 2020 Dec.
PubMed 34337481
Anttinen M, Makela P, Nurminen P, Yli-Pietila E, Suomi V, Sainio T, Saunavaara J, Taimen P, Blanco Sequeiros R, Bostrom PJ. Palliative MRI-guided transurethral ultrasound ablation for symptomatic locally advanced prostate cancer. Scand J Urol. 2020 Dec;54(6):481-486. doi: 10.1080/21681805.2020.1814857. Epub 2020 Sep 8.
PubMed 32897169

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Neoadjuvant Degarelix on MRI-guided Transurethral Ultrasound Ablation (TULSA) in Patients With Intermediate-risk Prostate Cancer: A Pilot Study
ClinicalTrials.gov ID: NCT05917860
Acronym / sponsor ID: NeoADT-TULSA / T1338/2023
Conditions: Localized Prostate Carcinoma, Castration-Naive Prostate Cancer, Intermediate Risk Prostate Cancer, Prostate Cancer
Keywords: MRI-guided transurethral ultrasound ablation, Androgen deprivation therapy, Neoadjuvant androgen deprivation therapy, TULSA, Prostate cancer, Thermal ablation, Therapeutic ultrasound, Ablation therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 15 participants (estimated)
Lead sponsor: Turku University HospitalOther government
Study start: 18 Jul 2023 (actual)
Primary completion: 31 Jan 2026 (actual)
Study completion: 31 Jan 2030 (estimated)
First posted: 26 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To measure the change in prostate and tumor size, tissue structural changes, and the blood flow within the prostate after ADT.
To measure the distribution of heating over the prostate after TULSA treatment.
To evaluate complications and genitourinary function and quality of life with patient-reported outcome measures.
To evaluate local cancer control and longer-term oncological outcomes after combination therapy of neoadjuvant ADT and TULSA treatment.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Procedure: Magnetic resonance imaging-guided transurethral ultrasound ablation of the prostate (TULSA) Drug: Degarelix

Arm	Type	Receives
3-month neoadjuvant Degarelix followed by whole-gland MRI-guided transurethral ultrasound ablation	Experimental	Drug: Degarelix, Device: MRI-guided transurethral ultrasound ablation (TULSA)After three months of neoadjuvant ADT with Degarelix, the subject will undergo whole-prostate gland MRI-guided transurethral ultrasound ablation (TULSA) (TULSA-PRO, Profound Medical Inc., Toronto, Canada) treatment.

Who may qualify

Ages: 40 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (14 listed)

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.
Inability to undergo MRI due to claustrophobia or contraindications (cardiac pacemaker, intracranial clips, etc.)
Severe kidney failure as determined by estimated glomerular filtration rate (eGFR) less than 30 ml/min per 1.73 m2

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DegarelixAlso: FirmagonDegarelix 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.	Drug	3-month neoadjuvant Degarelix followed by whole-gland MRI-guided transurethral ultrasound ablation
MRI-guided transurethral ultrasound ablation (TULSA)Also: TULSA-PROMRI-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.	Device	3-month neoadjuvant Degarelix followed by whole-gland MRI-guided transurethral ultrasound ablation

Primary outcome

Change in prostate volume after neoadjuvant ADT
Time frame: Baseline and four, eight, and 12 weeks of ADT.
The prostate volume change will be determined by comparing the prostate volume measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.
Change in prostate tumor volume after neoadjuvant ADT
Time frame: Baseline and four, eight, and 12 weeks of ADT.
The prostate tumor volume change will be determined by comparing the prostate tumor volume measured on T2-weighted MRI at four, eight, and 12 weeks of ADT to that at baseline.
The frequency and severity of adverse events
Time frame: Every follow-up visit until the first year of follow-up.
The frequency and severity of adverse events after neoadjuvant Degarelix and TULSA treatment will be determined by using the CTCAE v6.0 classification. Adverse events attributed to TULSA will also be graded using the Clavien Dindo classification for surgical complications.

19 secondary outcomes

Change in prostate tumor-capsule contact length after neoadjuvant ADT
Time frame: Baseline and four, eight, and 12 weeks of ADT.
Change in prostate vascular perfusion after neoadjuvant ADT
Time frame: Baseline and four, eight, and 12 weeks of ADT.
Change in prostate tumor vascular perfusion after neoadjuvant ADT
Time frame: Baseline and four, eight, and 12 weeks of ADT.
Change in periprostatic, prostate and tumor tissue structures after neoadjuvant ADT
Time frame: Baseline and four, eight, and 12 weeks of ADT.
Thermal coverage after whole-prostate gland TULSA
Time frame: Immediately after the TULSA procedure.
Change in quality of life (QoL) and functional status outcomes after neoadjuvant ADT
Time frame: Baseline and 12 weeks of ADT.
Change in lower urinary tract symptoms after neoadjuvant ADT
Time frame: Baseline and 12 weeks of ADT.
Change in erectile function after neoadjuvant ADT
Time frame: Baseline and 12 weeks of ADT.
Change in quality of life (QoL) and functional status outcomes after neoadjuvant ADT and whole-prostate gland TULSA
Time frame: Baseline and 12 weeks of ADT, and three, six, 12, 36 and 60 months after the TULSA procedure.
Change in lower urinary tract symptoms after neoadjuvant ADT and whole-prostate gland TULSA
Time frame: Baseline and 12 weeks of ADT, and three, six, 12, 36 and 60 months after the TULSA procedure.
Change in erectile function after neoadjuvant ADT and whole-prostate gland TULSA
Time frame: Baseline and 12 weeks of ADT, and three, six, 12, 36 and 60 months after the TULSA procedure.
The frequency and severity of adverse events during extended follow-up
Time frame: Every follow-up visit until the five years of follow-up.
Salvage therapy-free survival
Time frame: Every post-TULSA follow-up visit until the five years of follow-up.
Systemic therapy-free survival
Time frame: Every post-TULSA follow-up visit until the five years of follow-up.
Failure-free survival
Time frame: Every post-TULSA follow-up visit until the five years of follow-up.
Metastasis-free, prostate cancer-specific, and overall survival
Time frame: One, three and five years after the TULSA procedure.
Biochemical failure-free survival
Time frame: One, three, and five years after the TULSA procedure.
Freedom from biopsy-proven clinically-significant prostate cancer
Time frame: Twelve months after the TULSA procedure
Freedom from any biopsy-proven prostate cancer
Time frame: Twelve months after the TULSA procedure

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Background: PubMed 36465377Anttinen M, Blanco Sequeiros R, Bostrom PJ, Taimen P. Evolving imaging methods of prostate cancer and the emergence of magnetic resonance imaging guided ablation techniques. Front Oncol. 2022 Nov 17;12:1043688. doi: 10.3389/fonc.2022.1043688. eCollection 2022.
Background: PubMed 27595377Valerio M, Cerantola Y, Eggener SE, Lepor H, Polascik TJ, Villers A, Emberton M. New and Established Technology in Focal Ablation of the Prostate: A Systematic Review. Eur Urol. 2017 Jan;71(1):17-34. doi: 10.1016/j.eururo.2016.08.044. Epub 2016 Aug 29.
Background: PubMed 33021440Klotz L, Pavlovich CP, Chin J, Hatiboglu G, Koch M, Penson D, Raman S, Oto A, Futterer J, Serrallach M, Relle J, Lotan Y, Heidenreich A, Bonekamp D, Haider M, Tirkes T, Arora S, Macura KJ, Costa DN, Persigehl T, Pantuck AJ, Bomers J, Burtnyk M, Staruch R, Eggener S. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer. J Urol. 2021 Mar;205(3):769-779. doi: 10.1097/JU.0000000000001362. Epub 2020 Oct 6.
BackgroundEAU Guidelines 2023, presented at the EAU Annual Congress Milan 2023. ISBN 978-94-92671-16-5.
Background: PubMed 21440505Denham JW, Steigler A, Lamb DS, Joseph D, Turner S, Matthews J, Atkinson C, North J, Christie D, Spry NA, Tai KH, Wynne C, D'Este C. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol. 2011 May;12(5):451-9. doi: 10.1016/S1470-2045(11)70063-8.
Background: PubMed 25884478Hu J, Xu H, Zhu W, Wu F, Wang J, Ding Q, Jiang H. Neo-adjuvant hormone therapy for non-metastatic prostate cancer: a systematic review and meta-analysis of 5,194 patients. World J Surg Oncol. 2015 Feb 22;13:73. doi: 10.1186/s12957-015-0503-z.
Background: PubMed 23769268Nishiyama T. Serum testosterone levels after medical or surgical androgen deprivation: a comprehensive review of the literature. Urol Oncol. 2014 Jan;32(1):38.e17-28. doi: 10.1016/j.urolonc.2013.03.007. Epub 2013 Jun 13.
Background: PubMed 34084124Christie DRH, Mitina N, Sharpley CF. A prospective study of the effect of testosterone escape on preradiotherapy prostate-specific antigen kinetics in prostate cancer patients undergoing neoadjuvant androgen deprivation therapy. Curr Urol. 2021 Mar;15(1):63-67. doi: 10.1097/CU9.0000000000000008. Epub 2021 Mar 29.
Background: PubMed 12913699Klotz LH, Goldenberg SL, Jewett MA, Fradet Y, Nam R, Barkin J, Chin J, Chatterjee S; Canadian Uro-Oncology Group. Long-term followup of a randomized trial of 0 versus 3 months of neoadjuvant androgen ablation before radical prostatectomy. J Urol. 2003 Sep;170(3):791-4. doi: 10.1097/01.ju.0000081404.98273.fd.
Background: PubMed 17054269Kumar S, Shelley M, Harrison C, Coles B, Wilt TJ, Mason MD. Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006019. doi: 10.1002/14651858.CD006019.pub2.
Background: PubMed 18355899Sumitomo M, Hayashi M, Watanabe T, Tsugawa M, Noma H, Yamaguchi A, Nagakura K, Hayakawa M, Uchida T. Efficacy of short-term androgen deprivation with high-intensity focused ultrasound in the treatment of prostate cancer in Japan. Urology. 2008 Dec;72(6):1335-40. doi: 10.1016/j.urology.2007.12.041. Epub 2008 Mar 20.
BackgroundAoyagi, Teiichiro, and Isao Kuroda. Enhancement of HIFU Effect by Simultaneous Short Course Degarelix for Early Stage Prostate Cancer: A Pilot Study. Open Journal of Urology 6.03 (2016): 49-54.
Turku HIFU research centreLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mikael HJ Anttinen, MD, PhD principal investigator

Department of Urology, University of Turku and Turku University Hospital, Turku, Finland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in prostate volume after neoadjuvant ADT (time frame: Baseline and four, eight, and 12 weeks of ADT.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05917860, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.