Clinical trial NCT04379362: MRI-guided Focal Laser Ablation
Official title: Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Focal laser ablation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Biolitec
name: Soteria Medical
name: Siemens Corporation, Corporate Technology
First posted: 2020-05-07
Enrollment: 53
Sex: MALE
Minimum age (years): 45
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center, interventional treatment, non-randomized, open label, single arm, phase II study with a medical device.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Urine incontinence incontinence
timeFrame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Secondary outcomes:
measure: Local cancer control
timeFrame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
measure: International Prostate Symptom Score (IPSS)
timeFrame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
measure: Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)
timeFrame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
measure: International Consultation on Incontinence Questionnaire (ICIQ)
timeFrame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
measure: Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25
timeFrame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
measure: Complication rate
timeFrame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboudumc Nijmegen
name: Jurgen Fütterer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboudumc Nijmegen
name: Michiel Sedelaar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: