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RECRUITING
NCT05513443
NA

Prostate Cancer IRE Study (PRIS)

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

Official title: Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer

Key Details

Gender

MALE

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2022-09-01

Completion Date

2026-09-01

Last Updated

2025-01-20

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Irreversible electroporation, IRE

IRE involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death. The technique is used in Sweden today in radical ablative therapies in the treatment of tumors in the liver, kidney and pancreas. Prior to treatment a Foley catheter is placed. During the treatment, which takes place under anesthesia, the patient is placed in gynecological position and the tumour lesion is located with BK transrectal fusion ultrasound. Thereafter the needles are placed transperineal around the tumor in the prostate using a brachytherapy grid (17Ga Civco brachytherapy grid), guided by the ultrasound/MRI fusion images. Through the needles electrical pulses are then sent to treat the tumor in the center using the Nanoknife technique. After treatment patients are treated with diuretics to flush the kidneys post treatment.

PROCEDURE

Radical prostatectomy

Radical prostatectomy

RADIATION

Radiation therapy

Radiation therapy for prostate cancer

Locations (1)

Karolinska Institutet

Stockholm, Solna, Sweden