MRI-guided Focal Laser Ablation (Unicorn)

Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer

Magnetic resonance imaging-guided focal laser ablation of prostate cancer.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Focal laser ablation

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Annemarijke van Luijtelaar, MD; Phone Number: +31 (0)24 365 22 79; Email: Annemarijke.vanLuijtelaar@radboudumc.nl
• Study Contact Backup: Name: Joyce Bomers, PhD; Phone Number: +31 (0)24 365 22 79; Email: Joyce.Bomers@radboudumc.nl

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Recruiting
    • Radboudumc
    • Contact: Annemarijke van Luijtelaar, MD; Phone Number: +31 (0)24 365 22 79; Email: Annemarijke.vanLuijtelaar@radboudumc.nl
    • Contact: Joyce Bomers, PhD; Phone Number: +31 (0)24 365 22 79; Email: Joyce.Bomers@radboudumc.nl
    • Principal Investigator: Jurgen Fütterer, MD, PhD
    • Principal Investigator: Michiel Sedelaar, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria:

• MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
• Maximum MRI visible lesion size is ≤ 15 mm large axis;
• Life expectancy at inclusion of more 10 years;
• Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies;
• Criteria of low and intermediate risk of progression and eligibility for focal therapy (clinical stage of maximum T2c, maximum biopsy Gleason score of 4 + 3 on targeted biopsies, serum prostate specific antigen < 15 ng/ml);
• Patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice.

Exclusion criteria:

• History of prostate surgery;
• History of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis;
• History of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer);
• Severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score > 18;
• Tumor with MRI signs of extra-capsular extension or invasion of the seminal vesicles;
• Maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI;
• Impossibility to obtain a valid informed consent;
• Patients unable to undergo MR imaging, including those with contra-indications;
• Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection);
• Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging;
• Patients with evidence for nodal or metastatic disease;
• Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low or intermediate grade prostate cancer	Procedure: Focal laser ablation; Focal laser ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine incontinence incontinence	To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).	At inclusion, 3 months, 6 months, 12 months and 24 months follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local cancer control	To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies.	At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
International Prostate Symptom Score (IPSS)	To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. International Prostate Symptom Score (IPSS)	At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)	To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)	At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
International Consultation on Incontinence Questionnaire (ICIQ)	To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. the International Consultation on Incontinence Questionnaire (ICIQ).	At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25	To evaluate quality of life before and after FLA in men with prostate cancer by using a validated quality of life questionnaire (EORTC QLQ PR25).	At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
Complication rate	To evaluate the complication rate related to the technique	At inclusion , 3 months, 6 months, 12 months and 24 months follow up.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Siemens Corporation, Corporate Technology; Biolitec; Soteria Medical
• Investigators: Principal Investigator: Michiel Sedelaar, MD, PhD, Radboudumc Nijmegen; Principal Investigator: Jurgen Fütterer, MD, PhD, Radboudumc Nijmegen

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Focal laser ablation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: NL63647.091.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The investigators will be author of submitted manuscripts in case they fulfill criteria for authorship according to regulations of scientific journals. After scientific publication of the results the study protocol, relevant data and findings will be made publically available for other centers to implement (parts) of this research into their standard clinical practice if they wish to do so.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No