Focal treatment for localized prostate cancer using irreversible electroporation
Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer
NA · Karolinska Institutet · NCT05513443
This study is testing if a new treatment called irreversible electroporation can effectively treat localized prostate cancer in men and improve their quality of life compared to standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Karolinska Institutet (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Stockholm, Solna) |
| Trial ID | NCT05513443 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of treating localized prostate cancer diagnosed through MRI and biopsies using irreversible electroporation (IRE) compared to conventional radical treatments. The primary objective is to assess cancer control and health-related quality of life outcomes in men with unifocal localized prostate cancer. It is a randomized controlled trial that will analyze functional outcomes, adverse events, and survival rates over a 12-month period. The study includes patients from four hospitals in Stockholm County.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 and older with clinically significant intermediate-risk localized prostate cancer that is MRI-visible.
Not a fit: Patients with a history of prostate cancer treatment or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option with fewer side effects for patients with localized prostate cancer.
How similar studies have performed: Other studies have shown promise with focal therapies for prostate cancer, but the use of IRE specifically is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm, Solna
- Karolinska Institutet — Stockholm, Solna, Sweden (RECRUITING)
Study contacts
- Principal investigator: Anna Lantz, Ass Prof — Karolinska University Hospital and Karolinska Institutet
- Study coordinator: Anna Lantz, Ass Prof
- Email: anna.lantz@regionstockholm.se
- Phone: +46851770000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Focal treatment, IRE