MRI-guided Focal Laser Ablation

NCT04379362 | Unknown Phase 2

• 1 other identifier: NL63647.091.17
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Focal laser ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Local cancer control

  At inclusion , 3 months, 6 months, 12 months and 24 months follow up.

• 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)

  At inclusion, 3 months, 6 months, 12 months and 24 months follow up.

• 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

  At inclusion , 3 months, 6 months, 12 months and 24 months follow up.

Study Arms (1)

Low or intermediate grade prostate cancer

EXPERIMENTAL

Procedure: Focal laser ablation

Interventions

Focal laser ablation PROCEDURE

Focal laser ablation

Low or intermediate grade prostate cancer

Eligibility Criteria

• Age: 45 Years - 76 Years
• Gender Eligibility Details: Gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
• Maximum MRI visible lesion size is ≤ 15 mm large axis;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Biolitec: collaborator
• Soteria Medical: collaborator
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Radboudumc

Nijmegen, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jurgen Fütterer, MD, PhD

  Radboudumc Nijmegen

  PRINCIPAL INVESTIGATOR

• Michiel Sedelaar, MD, PhD

  Radboudumc Nijmegen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemarijke van Luijtelaar, MD

CONTACT

+31 (0)24 365 22 79; Annemarijke.vanLuijtelaar@radboudumc.nl

Joyce Bomers, PhD

CONTACT

+31 (0)24 365 22 79; Joyce.Bomers@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, interventional treatment, non-randomized, open label, single arm, phase II study with a medical device.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 7, 2020
• Study Start: December 14, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2024
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)