Neoadjuvant ADT with TULSA

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Turku University Central Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

29 Jun 2023 → ongoing

Decision date (initial)

2023-03-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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.

Conditions and MedDRA coding

Intermediate-risk prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Male age ≥ 40 years, candidate for radical Pca treatment
2. Estimated life expectancy > 8 years
3. At least one MRI-visible and biopsy-concordant tumor defined as Prostate Imaging–Reporting and Data System v2 (PI-RADS v2.1) ≥3
4. 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
5. PSA ≤ 20 ng/ml
6. No prior definitive treatment of Pca
7. Eligible for MRI
8. Eligible for general anesthesia (American Society of Anesthesiologists Class III or less
9. Patients taking 5-alpha reductase inhibitors (5-ARIs) are eligible if use is discontinued 12 months before and throughout the study period
10. 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 12

1. Prior Pca treatment with chemotherapy or hormonal therapy, including chemical or surgical castration, antiandrogen therapy, or androgen synthesis inhibitors
2. Relative or absolute contraindication to degarelix
3. Severe, active cardiovascular comorbidity including unstable angina pectoris, congestive heart failure, deep vein thrombosis, pulmonary embolism, or myocardial infarction within the last six months
4. Inability to undergo MRI due to claustrophobia or contraindications (cardiac pacemaker, intracranial clips, etc.
5. Prostate calcifications obstructing the planned ultrasound beam path in the line of sight of the MRI visible tumo
6. Prostate cysts at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumo
7. 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
8. History of chronic inflammatory conditions (e.g., inflammatory bowel disease) affecting the rectum (also includes rectal fistula and anal/rectal stenosis)
9. Hip replacement surgery or other metal in the pelvic area
10. Known allergy or contraindication to gadolinium or gastro-intestinal anti-spasmodic drug (e.g., glucagon, buscopan)
11. Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist
12. Secondary malignancy unless disease-free survival is > 8 years

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. To measure prostate and tumor volume change after neoadjuvant ADT using T2-weighted MRI.
2. To measure tumor-capsule contact length change after neoadjuvant ADT using T2-weighted MRI.
3. To measure the change in vascular perfusion to the prostate and tumor after neoadjuvant ADT using dynamic contrast-enhanced T1-weighted MRI.
4. To evaluate tissue structural changes after neoadjuvant ADT using quantitative analysis of the prostate’s intensity, shape, and texture on T2-weighted, quantitative T2 relaxation time mapping, and diffusion-weighted MRI.
5. To measure thermal coverage of the target volume achieved by whole-gland TULSA by comparing physician-defined target boundaries to MRI measurements of temperature distributions, thermal dose distributions, and acute treatment-induced perfusion defect.
6. To evaluate the subsequent safety, oncological, and quality-of-life outcomes of these patients for a period of 5 years.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Turku University Central Hospital

Sponsor organisation

Turku University Central Hospital

Address

Kiinamyllynkatu 4-8

City

Turku

Postcode

20520

Country

Finland

Scientific contact point

Organisation

Turku University Central Hospital

Contact name

Mikael Anttinen

Public contact point

Organisation

Turku University Central Hospital

Contact name

Mikael Anttinen

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications