eoadjuvant ADT with TULSA

Phase 1

• Conditions: Intermediate-risk prostate cancer; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

• Registration Number: CTIS2022-502067-38-00
• Lead Sponsor: Turku University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Male age = 40 years, candidate for radical Pca treatment, 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., 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 Pca: Clinical or radiological 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 Pca, 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 12 months before and throughout the study period

Exclusion Criteria

Prior Pca treatment with chemotherapy or hormonal therapy, including chemical or surgical castration, antiandrogen therapy, or androgen synthesis inhibitors, Known allergy or contraindication to gadolinium or gastro-intestinal anti-spasmodic drug (e.g., glucagon, buscopan), Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist, Secondary malignancy unless disease-free survival is > 8 years, 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., Prostate calcifications obstructing the planned ultrasound beam path in the line of sight of the MRI visible tumo, Prostate cysts at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumo, 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 histopatholog, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified