Prostate Cancer IRE Study (PRIS)

Karolinska Institute

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Radiation: Radiation therapy

Procedure: Irreversible electroporation, IRE

Procedure: Radical prostatectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05513443

4-1421/2022 (Other Identifier)

K2021-4853

Details and patient eligibility

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.

Full 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.

Enrollment

184 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

184 participants in 4 patient groups

PRIS 1, arm 1

Experimental group

Description:

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.

Treatment:

Procedure: Irreversible electroporation, IRE

PRIS 1, arm 2

Active Comparator group

Description:

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

Treatment:

Procedure: Radical prostatectomy

PRIS 2, arm 1

Experimental group

Description:

Treatment: