MRI-guided Focal Laser Ablation (Unicorn)

Radboud University Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Procedure: Focal laser ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04379362

NL63647.091.17

Details and patient eligibility

About

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

Enrollment: 53 estimated patients

Sex: Male

Ages: 45 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Low or intermediate grade prostate cancer

Experimental group

Treatment:

Procedure: Focal laser ablation