MRI-guided Focal Laser Ablation

Prostate Cancer Clinical Trial

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Official title:

Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04379362
• Other study ID #: NL63647.091.17
• Status: Recruiting
• Phase: Phase 2
• Start date: December 14, 2018
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2021
• Source: Radboud University
• Contact: Annemarijke van Luijtelaar, MD
• Phone: +31 (0)24 365 22 79
• Email: Annemarijke.vanLuijtelaar[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Focal laser ablation
Focal laser ablation

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (4)

Lead Sponsor	Collaborator
Radboud University	Biolitec, Siemens Corporation, Corporate Technology, Soteria Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Complication rate	To evaluate the complication rate related to the technique	At inclusion , 3 months, 6 months, 12 months and 24 months follow up.