Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Anesthetics

Diuretics

Liver Extracts

Pancrelipase

Pancreatin

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.

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

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

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.

Irreversible electroporation, IRE

Radical prostatectomy

Radiation therapy

Anna Lantz, Ass Prof

Olof Akre, Prof

Anna Lantz, MD PhD

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.

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.

Prostate Cancer IRE Study (PRIS)

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

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

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

IIEF score: International Index of Erectile Function, change. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

International Prostate Symptom Score (IPSS score), change. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

Expanded Prostate Cancer Index, EPIC-26, Q6 change in score. The EPIC-26 is a validated instrument that measures health-related quality of life across 5 PCa-specific domains. Consequently, the minimum symptom score (best HRQOL) = 0 and the maximum symptom score (worst HRQOL) = 12 in each domain. For consistency, the values assigned to each question range from 0 (best) to 4 (worst) regardless of whether there were 4 or 5 response options per question.

EQ5D; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

1. Need for additional focal or whole gland treatment or ADT
2. Need for whole gland treatment or ADT
3. Need for whole gland treatment or ADT or ISUP 2 at 12 mo biopsy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prostate Cancer IRE Study (PRIS)	NCT05513443	Prostate Cancer	Irreversible el... Radical prostat... Radiation thera...	40 Years -	Karolinska Institutet
Prostate Cancer IRE Study (PRIS)	NCT05513443	Prostate Cancer	Irreversible el... Radical prostat... Radiation thera...	40 Years -	Karolinska Institutet

Spots Global Cancer Trial Database for irreversible electroporation, ire