Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-Naive Prostate Cancer | — | UNRESOLVED | — |
| Intermediate Risk Prostate Cancer | — | UNRESOLVED | — |
| Localized Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
| MRI-guided transurethral ultrasound ablation (TULSA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3-month neoadjuvant Degarelix followed by whole-gland MRI-guided transurethral ultrasound ablation
- description
- 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.
- interventionNames
- Drug: Degarelix
- Device: MRI-guided transurethral ultrasound ablation (TULSA)
Primary outcomes (3)
- measure
- Change in prostate volume after neoadjuvant ADT
- timeFrame
- Baseline and four, eight, and 12 weeks of ADT.
- description
- 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.
- measure
- Change in prostate tumor volume after neoadjuvant ADT
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 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 * 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
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Ilari Virtanen, Pietari Mäkelä, Teija Sainio et al. · Int J Hyperthermia · Dec 1, 2026 · PMID 42733361 pubmed
- BACKGROUNDAnttinen 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. PMID 36465377
- BACKGROUNDValerio 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. PMID 27595377
- BACKGROUNDKlotz 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.