Transperineal Laser Ablation for Low and Intermediate Risk Prostate Cancer: a Single Cohort Analysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- San Carlo di Nancy Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Oncological outcomes PSA
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this prospective study is to test the efficacy of Echolaser transperineal focal therapy in patients with low- and intermediate risk prostate cancer. The main question it aims to answer are: 1. short and intermediate term oncological outcomes after laser focal therapy, 2. functional outcomes and quality of life after treatment. Participants affected by low risk prostate cancer will undergo trans perineal laser focal therapy. Multiparametric prostate MRI will be perform after 3 and 12 months for oncological control. Re-fusion biopsy will be perform after 12 months. Functional outcomes and quality of life will be assess at 3, 6 and 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with low- and intermediate risk prostate cancer classified as International Society for Urological Pathology, ISUP 1-2.
Exclusion Criteria
- •patients diagnosed with urothelial cancer
- •contraindications for MRI
- •Multifocal prostate cancer
Outcomes
Primary Outcomes
Oncological outcomes PSA
Time Frame: 12 months after treatment.
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Oncological outcomes Re-biopsy
Time Frame: 12 months after treatment
Evaluation of histological outcomes after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual negativity for cancer in a re-biopsy.
Oncological outcomes MRI
Time Frame: 12 months after treatment
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by multiparametric prostate MRI. Specifically, 1. complete ablation, 2. partial ablation or 3. persistence of cancer will be identified.
Secondary Outcomes
- Quality of life Pain(day after surgery)
- Functional outcomes Erection(3, 6 and 12 months after treatment.)
- Functional outcomes IPSS and IPSS QoL(3, 6 and 12 months after treatment.)
- Functional outcomes Continence(3, 6 and 12 months after treatment.)
- Functional outcomes Ejaculation(3, 6 and 12 months after treatment.)