Clinical trial NCT05513443: Prostate Cancer IRE Study (PRIS)
Official title: Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Focal treatment
IRE
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2022-08-24
Enrollment: 184
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary outcome in PRIS 1: Urinary continence
timeFrame: 12 months postoperatively
measure: Primary outcome in PRIS 2: Irritative urinary symptoms
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Erectile dyfunction
timeFrame: 12 months postoperatively
measure: Voiding function
timeFrame: 12 months postoperatively
measure: Bowel function
timeFrame: 12 months postoperatively
measure: Adverse events
timeFrame: 3 months postoperatively
measure: Quality of life, EuroQoL-5 Dimensions
timeFrame: 12 months postoperatively
measure: Treatment Failure, experimental arms
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
measure: Treatment Failure, control arm (surgery)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
measure: Treatment Failure, control arm (radiation)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Solna
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Anna Lantz, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: