Clinical trial NCT05584787: Transperineal Laser Ablation for Low- and Intermediate Risk Prostate Cancer: a Single Cohort Analysis
Official title: Transperineal Laser Ablation for Low and Intermediate Risk Prostate Cancer: a Single Cohort Analysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
focal therapy
Echolaser
transperineal laser ablation
TPLA
Lead sponsor: San Carlo di Nancy Hospital
Sponsor class: OTHER
Collaborators: name: Elesta S.R.L.
First posted: 2022-10-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Oncological outcomes MRI
timeFrame: 3 months after treatment
measure: Oncological outcomes MRI
timeFrame: 12 months after treatment
measure: Oncological outcomes PSA
timeFrame: 3 months after treatment.
measure: Oncological outcomes PSA
timeFrame: 6 months after treatment.
measure: Oncological outcomes PSA
timeFrame: 12 months after treatment.
measure: Oncological outcomes Re-biopsy
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Functional outcomes IPSS and IPSS QoL
timeFrame: 3, 6 and 12 months after treatment.
measure: Quality of life Pain
timeFrame: day after surgery
measure: Functional outcomes Continence
timeFrame: 3, 6 and 12 months after treatment.
measure: Functional outcomes Erection
timeFrame: 3, 6 and 12 months after treatment.
measure: Functional outcomes Ejaculation
timeFrame: 3, 6 and 12 months after treatment.
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Carlo di Nancy Hospital
state: RM
Study officials:
affiliation: San Carlo di Nancy Hospital
name: Pierluigi Bove, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Riel LAMJG, van Kollenburg RAA, Vis AN, van Leeuwen PJ, de Reijke TM, de Bruin DM, Oddens JR. Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study. Eur Urol Open Sci. 2022 Apr 2;39:48-54. doi: 10.1016/j.euros.2022.02.012. eCollection 2022 May.