Last updated: October 25, 2022
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Prostate Disorders
Treatment
N/AClinical Study ID
NCT05370482
2021-13069
Ages 45-76 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 focaltherapy;
- 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 thestudy, in accordance with the recommendations of good practice.
Exclusion
Exclusion Criteria:
- History of prostate surgery;
- history of radiation therapy or pelvic trauma; history of proved acute or chronicprostatitis;
- history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skincancer);
- severe urinary symptoms associated with benign hyperplasia of the prostate, anddefined 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, rectalpathology or abdomino perineal resection);
- metallic hip implant or any other metallic implant or device that distorts localmagnetic 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
Study Design
Total Participants: 10
Study Start date:
April 11, 2022
Estimated Completion Date:
April 11, 2025
Study Description
Connect with a study center
Radboudumc
Nijmegen, Gelderland 6525 GA
NetherlandsActive - Recruiting
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