Neoadjuvant ADT with TULSA
Key facts
- Where
- Turku, FinnországSee the site
- Phase
- 1. fázis
Where in Finnország
- Turku University HospitalTurku, FinnországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Turku University Central Hospital
- Trial code
- EU 2022-502067-38-00
- Record updated
- 2023. május 12.
- Original description
The first part of the study, the pre-TULSA ADT period, aims to investigate the impact of short-term ADT using degarelix on prostate and tumor characteristics on MRI, and the second part, the post-TULSA period, the synergistic impact of combining neoadjuvant degarelix with whole-gland TULSA on treatment and clinical outcomes.Read full original descriptionShow less
Effect of neoadjuvant Degarelix on MRI-guided transurethral ultrasound ablation in patients with intermediate-risk prostate cancer: A pilot study
The first part of the study, the pre-TULSA ADT period, aims to investigate the impact of short-term ADT using degarelix on prostate and tumor characteristics on MRI, and the second part, the post-TULSA period, the synergistic impact of combining neoadjuvant degarelix with whole-gland TULSA on treatment and clinical outcomes.
Inclusion: 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: Prior Pca treatment with chemotherapy or hormonal therapy, including chemical or surgical castration, antiandrogen therapy, or androgen synthesis inhibitors; Hip replacement surgery or other metal in the pelvic area; 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; 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; 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); Secondary malignancy unless disease-free survival is > 8 years; Relative or absolute contraindication to degarelix; 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.