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

Trial Title: Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer

NCT ID: NCT05917860

Condition: Localized Prostate Carcinoma
Castration-Naive Prostate Cancer
Intermediate Risk Prostate Cancer
Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
MRI-guided transurethral ultrasound ablation
Androgen deprivation therapy
Neoadjuvant androgen deprivation therapy
TULSA
Prostate cancer
Thermal ablation
Therapeutic ultrasound
Ablation therapy

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Procedure: Magnetic resonance imaging-guided transurethral ultrasound ablation of the prostate (TULSA) Drug: Degarelix

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Degarelix
Description: Degarelix is injected subcutaneously into the fatty tissue of the abdomen. A typical protocol consists of a starting dose of 240 mg with a maintenance dose of 80 mg administered every 28 days. In this study, one starting dose and two maintenance doses of Degarelix will be administered between baseline and TULSA treatment in accordance with the terms of Degarelix marketing authorizations.
Arm group label: 3-month neoadjuvant Degarelix followed by whole-gland MRI-guided transurethral ultrasound ablation

Other name: Firmagon

Intervention type: Device
Intervention name: MRI-guided transurethral ultrasound ablation (TULSA)
Description: MRI-guided transurethral ultrasound ablation (TULSA) (TULSA-PRO, Profound Medical Inc., Toronto, Canada) will be used to deliver whole-prostate gland treatment in accordance with the terms of TULSA marketing authorizations. The treating physicians will contour the entire prostate gland for a whole gland ablation.
Arm group label: 3-month neoadjuvant Degarelix followed by whole-gland MRI-guided transurethral ultrasound ablation

Other name: TULSA-PRO

Summary: 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.

Detailed description: Androgen deprivation therapy (ADT) has been shown to reduce prostate and tumor size. In this study, magnetic resonance imaging (MRI) is used to investigate the effect of Degarelix ADT on the properties of prostate tissue that can affect the heating of the tissues in the TULSA procedure. The main goal is to find out if ADT can change the tissue structure in a way that improves the ability of the TULSA procedure to heat tissues and better kill the diseased tissue, reducing the chance of the disease reoccurring. ADT and the TULSA procedure can help patients with more aggressive diseases avoid the adverse effects associated with surgery or radiation therapy. Specific objectives are: 1. To measure the change in prostate and tumor size, tissue structural changes, and the blood flow within the prostate after ADT. 2. To measure the distribution of heating over the prostate after TULSA treatment. 3. To evaluate complications and genitourinary function and quality of life with patient-reported outcome measures. 4. To evaluate local cancer control and longer-term oncological outcomes after combination therapy of neoadjuvant ADT and TULSA treatment. About 15 subjects will participate. Each will receive Degarelix for three months, followed by whole-prostate gland TULSA treatment, and be followed for five years. Throughout the study, subjects will receive MRI scans and complete questionnaires regarding functional status and quality of life to understand the side effects.

Criteria for 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

Gender: Male

Minimum age: 40 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Turku University Hospital

Address:
City: Turku
Zip: 20521
Country: Finland

Status: Recruiting

Contact:
Last name: Mikael HJ Anttinen, MD, PhD

Phone: +358-2-3133650
Email: mikael.anttinen@tyks.fi

Contact backup:
Last name: Kaisa Reunanen
Email: kaisa.reunanen@tyks.fi

Start date: October 1, 2023

Completion date: December 31, 2030

Lead sponsor:
Agency: Turku University Hospital
Agency class: Other

Source: Turku University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05917860
http://hifu.utu.fi