malign neoplasmata of the prostate Prostate Cancer
Conditions
Interventions
All subjects undergo a transperineal laser ablation of their prostate under
local anaesthesia using the Echolaser® system. One or two laser fibres are
placed in the prostate inducing coagulative nec
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male - *40 years of age - Histopathological confirmed organ-confined prostate cancer - Indication for a radical prostatectomy - Prostate volume *40mL - Ability of the patient to stop anticoagulant therapy according to standard hospital pre-operative protocol - Signed informed consent
Exclusion criteria
Exclusion criteria: - Prior or concurrent treatment for prostate cancer (biologicals, chemotherapy, radiotherapy) - Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy - Other conditions / status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter for histological ablative efficacy is assessed on histopathological analysis of the prostatic tissue after radical prostatectomy by means of the absence of vital cells in the treated prostate zone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are the determination of the ablation site by imaging modalities (CEUS and mpMRI) compared to the histopathological analysis. Secondary parameter for feasibility is the number of successful TPLA procedures and for safety is the number of grade 3 adverse events. Secondary parameters for functional outcomes are validated questionnaires. | — |
Countries
Netherlands
Outcome results
None listed