| NCT ID | NCT05513443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2022-09-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to evaluate the feasibility to treat localized prostate cancer diagnosed with MRI and targeted/systematic biopsies, with IRE in comparison with conventional radical treatments with the primary objective to locally control the tumour with a minimum of side effects.
Eligibility Criteria
Inclusion Criteria: * Age at inclusion ≥ 40 years * MRI-visible lesion * EPE 3\* \<1.5 cubic cm3 lesion volume * Gleason score 3 + 4 or 4 + 3 from a single MRI-visible lesion without any Gleason grade 4 in systematic biopsies outside of the target * PSA level ≤ 20 ng/ml * Clinical stage ≤ T2c disease * Unifocal significant disease * Life expectancy of ≥ 10 years * Sufficient proficiency in the Swedish language to understand written and verbal information about the trial, its consent process and the study questionnaires * Extraprostatic extension; 5-grade Likert scale 1= Exclusion Criteria: * Intraductal tumour * History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment * History of cardiac arrythmias * Pacemaker * Renal insufficiency; GFR\<30 * Severe illnesses such as concomitant cancers, severe cardio-vascular disease or dementia * Contraindications for magnetic resonance imaging (MRI) e.g. magnetic cerebral clips, cochlear implants or severe claustrophobia * History of bladder cancer * History of previous pelvic radiotherapy
Contact & Investigator
Anna Lantz, Ass Prof
PRINCIPAL INVESTIGATOR
Karolinska University Hospital and Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05513443 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05513443 currently recruiting?
Yes, NCT05513443 is actively recruiting participants. Contact the research team at anna.lantz@regionstockholm.se for enrollment information.
Where is the NCT05513443 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05513443 clinical trial?
NCT05513443 is sponsored by Karolinska Institutet. The principal investigator is Anna Lantz, Ass Prof at Karolinska University Hospital and Karolinska Institutet. The trial plans to enroll 184 participants.
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