prostate cancer prostate carcinoma
Conditions
Interventions
Patient group A will undergo additional MR-guided focal laser ablation before
they undergo radical prostatectomy and patient group B will receive MR-guided
focal laser ablation as main therapy for t
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria counting for both groups: • Newly diagnosed and biopsy proven prostate cancer • Low risk patients (PSA
Exclusion criteria
Exclusion criteria: • 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 |
|---|---|
| The feasibility of MR-guided focal laser ablation in vivo in newly diagnosed PCa patients. Potential complications are recorded, and the success rate will be determined by MR-imaging after 1 - 3 weeks and a combination of MR imaging and MR-guided biopsy after 6, 12, 18, 24 and 36 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To determine the accuracy of laser fibre placement under MR guidance by measuring the 3D error at the MR images retrospectively. • To correlate the MR results from multimodality MR and temperature mapping with the pathological results. • To determine the role of imaging in predicting histological outcomes of transrectal focal laser ablation therapy in the treatment of localised prostate cancer. | — |
Countries
Netherlands
Outcome results
None listed