Status:
UNKNOWN
MRI-guided Focal Laser Ablation
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Biolitec
Soteria Medical
Conditions:
Prostate Cancer
Eligibility:
MALE
45-76 years
Phase:
PHASE2
Brief Summary
Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04379362
Start Date
December 14 2018
End Date
July 1 2024
Last Update
September 22 2021
Active Locations (1)
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1
Radboudumc
Nijmegen, Netherlands, 6500 HB