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Neoadjuvant ADT with TULSA
EU CTIS ID: 2022-502067-38-00
What this study is testing
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.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.