Prostate cancer Prostate carcinoma
Conditions
Interventions
MRI-guided focal laser ablation of prostate cancer
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging); • maximum MRI visible lesion size is
Exclusion criteria
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 extra-capsular extension or invasion of the seminal vesicles; • patients with >2 lesions; • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint • Technical success, as determined by: o Completion of the laser ablation without technical failures o Achievement of complete ablation shown by MRI after treatment calculated using image co-registration software. • Total procedure time • Total number of fiber positions and ablations needed • Procedure-related adverse events and complications following SIR criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| • Tumor response measured with MRI 6 months after treatment (Lack of enhancement on dynamic contrast enhanced MR imaging in the treated area) • Progression free survival at 6 months • Functional outcome (i.e. urinary incontinence, and erectile dysfunction). The IPSS and IIEF-5 (erectile dysfunctioning) at 6 weeks, 3, 6 and 12 months. • Complication rates according to SIR system • Local progression free survival | — |
Countries
Netherlands
Outcome results
None listed