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

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 ProstateImaging-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 orless)

• Patients taking 5-alpha reductase inhibitors (5-ARIs) are eligible if use isdiscontinued three months before and throughout the study period.

• Informed consent: The patient must speak Finnish, English, or Swedish and must beable to understand the meaning of the study. The patient must be willing and able tosign the appropriate Ethics Committee (EC) approved informed consent documents inthe presence of the designated staff.

Exclusion Criteria:

• Prior prostate cancer treatment with chemotherapy or hormonal therapy, includingchemical or surgical castration, antiandrogen therapy, or androgen-receptorsignaling inhibitors.

• Relative or absolute contraindication to Degarelix

• Severe, active cardiovascular comorbidity including unstable angina pectoris,congestive heart failure, deep vein thrombosis, pulmonary embolism, or myocardialinfarction within the last six months.

• Inability to undergo MRI due to claustrophobia or contraindications (cardiacpacemaker, 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 ofsight of the MRI visible tumor

• Prostate cysts at the prostate capsule within the planned ultrasound beam path inthe 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 membraneantigen-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-spasmodicdrug glucagon

• Concomitant treatment with medications contraindicated to Glucagen used asantispasmolytic agent during TULSA treatment (e.g., Feochromocytoma)

• Any other conditions that might compromise patient safety, based on the clinicaljudgment of the responsible urologist

• Another primary malignancy unless disease-free survival is > 8 years