Prostate Cancer IRE Study (PRIS)

NCT05513443 | Recruiting DMC

• 2 other identifiers: K2021-48534-1421/2022
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Focal treatment; IRE

Outcome Measures

Primary Outcomes (2)

• Primary outcome in PRIS 1: Urinary continence

  Urinary incontinence defined by Q3 in EPIC-26, ≥1 pad/day ("Yes") versus none ("No")

  12 months postoperatively

• Primary outcome in PRIS 2: Irritative urinary symptoms

  Irritative urinary symptoms defined by Q4e in EPIC-26, Moderate/big problem ("Yes") Versus no/small problem ("No")

  12 months postoperatively

Secondary Outcomes (8)

• Erectile dyfunction

  12 months postoperatively

• Voiding function

  12 months postoperatively

• Bowel function

  12 months postoperatively

• Adverse events

  3 months postoperatively

• Quality of life, EuroQoL-5 Dimensions

  12 months postoperatively

Study Arms (4)

PRIS 1, arm 1

EXPERIMENTAL

Men randomized to the experimental arms will be offered focal treatment of prostate cancer with IRE technology. IRE stands for "irreversible electroporation" and involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death.

Procedure: Irreversible electroporation, IRE

PRIS 1, arm 2

ACTIVE COMPARATOR

Men eligible for radical prostatectomy and randomized to the control arm will undergo radical prostatectomy in line with national guidelines.

Procedure: Radical prostatectomy

PRIS 2, arm 1

EXPERIMENTAL

Men randomized to the experimental arms will be offered focal treatment of prostate cancer with IRE technology. IRE stands for "irreversible electroporation" and involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death.

Procedure: Irreversible electroporation, IRE

PRIS 2, arm 2

ACTIVE COMPARATOR

Men eligible for radiation therapy and randomized to the control arm will undergo radiation therapy in line with national guidelines.

Radiation: Radiation therapy

Interventions

Irreversible electroporation, IRE PROCEDURE

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.

PRIS 1, arm 1; PRIS 2, arm 1

Radical prostatectomy PROCEDURE

Radical prostatectomy

PRIS 1, arm 2

Radiation therapy RADIATION

Radiation therapy for prostate cancer

PRIS 2, arm 2

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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=

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Solna, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Electroporation; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Therapeutics

Study Officials

• Anna Lantz, Ass Prof

  Karolinska University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Lantz, Ass Prof

CONTACT

+46851770000; anna.lantz@regionstockholm.se

Olof Akre, Prof

CONTACT

olof.akre@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Principal Investigator Associate Professor

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 24, 2022
• Study Start: September 1, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)