Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT05917860
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05917860
Study Brief:
Protocol Section:
NCT05917860