Actively Recruiting
Prostate Cancer IRE Study (PRIS) - Comparing Focal Irreversible Electroporation to Radical Surgery or Radiation for Localized Prostate Cancer
Led by Karolinska Institutet · Updated on 2025-01-20
184
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for localized prostate cancer using irreversible electroporation (IRE) compared to conventional radical therapies like prostatectomy or radiation. This randomized controlled exploratory trial focuses on men with clinically significant intermediate-risk prostate cancer diagnosed by MRI and targeted biopsies. The study aims to assess tumor control and minimize side effects, particularly looking at urinary continence and irritative urinary symptoms one year after treatment. The trial includes two study groups: men eligible for radical prostatectomy randomized to either focal IRE treatment or prostatectomy, and men eligible for radiation therapy randomized to either focal IRE or radiation. The IRE procedure involves placing needles transperineally around the tumor guided by ultrasound and MRI fusion, delivering electrical pulses under anesthesia. Conventional treatments include standard radical prostatectomy or radiation therapy. Treatment starts within six weeks after randomization. Participants will complete questionnaires on functional outcomes and quality of life, with assessments including urinary continence, urinary symptoms, erectile function, adverse events, and survival outcomes over 12 months. The study includes monitoring of side effects and progression-free survival. This research takes place in multiple hospitals in Stockholm and requires participants to have sufficient proficiency in Swedish for consent and questionnaires.
CONDITIONS
Official Title
Prostate Cancer IRE Study (PRIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Presence of an MRI-visible prostate lesion
- Lesion volume less than 1.5 cubic centimeters without extraprostatic extension
- Gleason score 3+4 or 4+3 from a single MRI-visible lesion without Gleason grade 4 outside the target
- PSA level 20 ng/ml or lower
- Clinical stage T2c or less
- Unifocal significant prostate cancer
- Life expectancy of at least 10 years
- Sufficient proficiency in Swedish to understand trial information and questionnaires
You will not qualify if you...
- Presence of intraductal tumor
- Previous prostate cancer treatment including surgery, radiation, chemotherapy, or hormonal therapy
- History of cardiac arrhythmias or having a pacemaker
- Renal insufficiency with GFR below 30
- Severe illnesses such as other cancers, severe cardiovascular disease, or dementia
- Contraindications to MRI such as magnetic cerebral clips, cochlear implants, or severe claustrophobia
- History of bladder cancer
- Previous pelvic radiotherapy
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Trial Site Locations
Total: 1 location
1
Karolinska Institutet
Stockholm, Solna, Sweden, 17177
Actively Recruiting
Research Team
A
Anna Lantz, Ass Prof
O
Olof Akre, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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