Focal Laser Ablation, MRI, Prostate Cancer
Conditions
Keywords
MR-guided therapy, Focal laser ablation, Prostate cancer
Brief summary
Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.
Interventions
DEVICEMR-guided focal laser ablation
Sponsors
Canisius-Wilhelmina Hospital
Ziekenhuisgroep Twente
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed and biopsy proven prostate cancer * Intermediate risk patients (PSA \<= 20 ng/mL, Gleason ≤ 7, T2b) * No previous treatment for prostate cancer * Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images * Signed informed consent by patient * Age 18 years or older * Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)
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) \< 40 mL/min/1.73 m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 36 months. | The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months. |
Countries
Netherlands
Outcome results
None listed