MRI-guided Focal Laser Ablation

  • STATUS
    Recruiting
  • participants needed
    53
  • sponsor
    Radboud University
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Updated on 19 February 2024
See if I qualify
MRI
prostate specific antigen
transrectal ultrasound
laser ablation
diffusion weighted imaging

Summary

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

Details
Condition Malignant neoplasm of prostate, Prostatic disorder
Age 45years - 76years
Treatment Focal laser ablation
Clinical Study IdentifierNCT04379362
SponsorRadboud University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
Tumor with cribriform morphology
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
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prostate specific antigen
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