Prostate Cancer IRE Study (PRIS)

NCT ID: NCT05513443

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-09-01

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.

Detailed Description

OBJECTIVES The aim of the proposed research is to evaluate the cancer control, genitourinary, rectal and overall health-related quality of life outcomes of focal therapy for unifocal localized prostate cancer using irreversible electroporation (IRE).

PRIMARY AIM

• To evaluate functional outcomes in men treated for unifocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy

SECONDARY AIMS

• To evaluate adverse events in men treated for unilfocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
• To evaluate progression free and treatment free survival in men treated for unifocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
• Economic evaluation of each technique

TRIAL DESIGN This study is a randomized controlled exploratory trial comparing focal therapy to conventional radical treatment of prostate cancer with the primary aim to evaluate functional outcomes 12 months after treatment.

Patients will be included from 4 different hospitals within the Stockholm County; Karolinska University Hospital, Danderyd Hospital, St Görans Hospital, Södersjukhuset. Eligible patients, after MRI and targeted/systematic biopsies, will be men with clinically significant intermediate-risk PCa or dominant unifocal clinically significant intermediate-risk and small contralateral low-risk disease without previous history of prostate cancer treatment.

Potential study participants will have a visit scheduled together with an urologist and oncologist, where a treatment decision of radical prostatectomy or radiation therapy will be done together with the patient. At this visit the patient will receive oral and written information about the study. If the patient is interested in participating, a baseline visit is scheduled during which informed consent is obtained and the patient randomized to one of two standard treatments or focal treatment.

Patients eligible for radical prostatectomy will be randomized in study 1 to focal treatment or radical prostatectomy. Patients eligible for radiation therapy will be randomized in study 2 to focal treatment or radiation therapy. Time between randomization and treatment will be <= 6 weeks.

Patients will be asked to fill out study specific questionnaires with questions on functional outcomes and quality of life.

Main outcome measurement in study 1 will be urinary incontinence at 12 months post treatment and in study 2 irritative urinary symptoms 12 months post treatment. Further outcomes will be erectile dysfunction, adverse events, progression-free and treatment-free survival.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRIS 1, arm 1

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.

Group Type: EXPERIMENTAL

Irreversible electroporation, IRE

Intervention Type: 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 2

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

Group Type: ACTIVE_COMPARATOR

Radical prostatectomy

Intervention Type: PROCEDURE

Radical prostatectomy

PRIS 2, arm 1

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.

Group Type: EXPERIMENTAL

Irreversible electroporation, IRE

Intervention Type: 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 2, arm 2

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

Group Type: ACTIVE_COMPARATOR

Radiation therapy

Intervention Type: RADIATION

Radiation therapy for prostate cancer

Interventions

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.

Intervention Type: PROCEDURE

Radical prostatectomy

Radical prostatectomy

Intervention Type: PROCEDURE

Radiation therapy

Radiation therapy for prostate cancer

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Anna Lantz

MD PhD Principal Investigator Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Lantz, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital and Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, Solna, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Anna Lantz, Ass Prof

Role: CONTACT

anna.lantz@regionstockholm.se

+46851770000

Olof Akre, Prof

Role: CONTACT

olof.akre@regionstockholm.se

Facility Contacts

Anna Lantz, MD PhD

Role: primary

Other Identifiers

K2021-4853

Identifier Type: -

Identifier Source: org_study_id

4-1421/2022

Identifier Type: OTHER

Identifier Source: secondary_id