Transperineal Laser Ablation for Low- and Intermediate Risk Prostate Cancer: a Single Cohort Analysis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TPLA in patients with prostate cancer Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy. |
Procedure: Soractelite Echolaser Transperineal focal laser ablation
US/MRI fusion laser ablation of low- and intermediate risk prostate cancer
|
Outcome Measures
Primary Outcome Measures
- Oncological outcomes MRI [3 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.
- Oncological outcomes MRI [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.
- Oncological outcomes PSA [3 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 PSA [6 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 PSA [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 [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.
Secondary Outcome Measures
- Functional outcomes IPSS and IPSS QoL [3, 6 and 12 months after treatment.]
Evaluation of lower urinary tract symptoms and quality of life after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the IPSS, International Prostatic Symptoms Score.
- Quality of life Pain [day after surgery]
Evaluation of pain after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the visual analogue scale (VAS). The VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter to be measured (pain) from 0 to 10 orientated from the left (no pain) to the right (unbearable pain).
- Functional outcomes Continence [3, 6 and 12 months after treatment.]
Evaluation of continence rate after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the ICIQ-SF, International Consulation on Incontinence Questionnaire - Short Form.
- Functional outcomes Erection [3, 6 and 12 months after treatment.]
Evaluation of erectile function after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the IIEF5, International Index of Erectile Function.
- Functional outcomes Ejaculation [3, 6 and 12 months after treatment.]
Evaluation of ejaculatory function after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the MSHQ SF, Male Sexual Health Questionnaire short form.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Carlo di Nancy Hospital | Roma | RM | Italy | 00175 |
Sponsors and Collaborators
- San Carlo di Nancy Hospital
- Elesta S.R.L.
Investigators
- Principal Investigator: Pierluigi Bove, MD, San Carlo di Nancy Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TPLA K