Prostate Cancer
Conditions
Keywords
prostate cancer, focal therapy, Echolaser, transperineal laser ablation, TPLA
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.
Interventions
PROCEDURESoractelite Echolaser Transperineal focal laser ablation
US/MRI fusion laser ablation of low- and intermediate risk prostate cancer
Sponsors
Elesta S.R.L.
San Carlo di Nancy Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Countries
Italy
Contacts
Primary ContactValerio Iacovelli, MD, PhD
Backup ContactPierluigi Bove, MD
Outcome results
None listed