Status:
UNKNOWN
MRI-guided Focal Laser Ablation Prostate Cancer
Lead Sponsor:
Radboud University Medical Center
Conditions:
Prostate Neoplams, Magnetic Resonance Imaging, Laser Ablation
Eligibility:
MALE
45-76 years
Phase:
NA
Brief Summary
Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are ga...
Detailed Description
Prostate cancer is the most frequent non-cutaneous malignancy in the western male population, with almost 13,600 newly diagnosed patients in the Netherlands in 2019. Due to widespread use of the prost...
Eligibility Criteria
Inclusion
- MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
- maximum MRI visible lesion size is ≤ 20 mm large axis;
- age 45 to 76 years old;
- life expectancy at inclusion of more 10 years;
- diagnosis of prostate cancer confirmed by targeted biopsy;
- 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
- 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) \< 40 mL/min/1.73 m2
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 11 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05370482
Start Date
April 11 2022
End Date
April 11 2025
Last Update
October 26 2022
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA