Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy evaluation using post-radical Prostatectomy Histological Analysis

Completed

Conditions: malign neoplasmata of the prostate
Prostate Cancer
10038597
10046590
10036958

Registration Number: NL-OMON48033

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter for histological ablative efficacy is assessed on<br /><br>histopathological analysis of the prostatic tissue after radical prostatectomy<br /><br>by means of the absence of vital cells in the treated prostate zone. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are the determination of the ablation site by imaging<br /><br>modalities (CEUS and mpMRI) compared to the histopathological analysis.<br /><br>Secondary parameter for feasibility is the number of successful TPLA procedures<br /><br>and for safety is the number of grade 3 adverse events. Secondary parameters<br /><br>for functional outcomes are validated questionnaires. </p><br>