Actively Recruiting

Phase Not Applicable
Age: 40Years +
MALE
NCT05513443

Prostate Cancer IRE Study (PRIS)

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

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.

CONDITIONS

Official Title

Prostate Cancer IRE Study (PRIS)

Who Can Participate

Age: 40Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Karolinska Institutet

Stockholm, Solna, Sweden, 17177

Actively Recruiting

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Research Team

A

Anna Lantz, Ass Prof

CONTACT

O

Olof Akre, Prof

CONTACT

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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