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Transperineal Laser Ablation for Low- and Intermediate Risk Prostate Cancer: a Single Cohort Analysis

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Soractelite Echolaser Transperineal focal laser ablation
Sponsored by
San Carlo di Nancy Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, focal therapy, Echolaser, transperineal laser ablation, TPLA

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • San Carlo di Nancy HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TPLA in patients with prostate cancer

Arm Description

Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy.

Outcomes

Primary Outcome Measures

Oncological outcomes MRI
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
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
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Oncological outcomes PSA
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Oncological outcomes PSA
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
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
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
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
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
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
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.

Full Information

First Posted
October 7, 2022
Last Updated
October 16, 2022
Sponsor
San Carlo di Nancy Hospital
Collaborators
Elesta S.R.L.
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1. Study Identification

Unique Protocol Identification Number
NCT05584787
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
San Carlo di Nancy Hospital
Collaborators
Elesta S.R.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, focal therapy, Echolaser, transperineal laser ablation, TPLA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TPLA in patients with prostate cancer
Arm Type
Experimental
Arm Description
Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy.
Intervention Type
Procedure
Intervention Name(s)
Soractelite Echolaser Transperineal focal laser ablation
Intervention Description
US/MRI fusion laser ablation of low- and intermediate risk prostate cancer
Primary Outcome Measure Information:
Title
Oncological outcomes MRI
Description
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.
Time Frame
3 months after treatment
Title
Oncological outcomes MRI
Description
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.
Time Frame
12 months after treatment
Title
Oncological outcomes PSA
Description
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Time Frame
3 months after treatment.
Title
Oncological outcomes PSA
Description
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Time Frame
6 months after treatment.
Title
Oncological outcomes PSA
Description
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Time Frame
12 months after treatment.
Title
Oncological outcomes Re-biopsy
Description
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.
Time Frame
12 months after treatment
Secondary Outcome Measure Information:
Title
Functional outcomes IPSS and IPSS QoL
Description
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.
Time Frame
3, 6 and 12 months after treatment.
Title
Quality of life Pain
Description
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).
Time Frame
day after surgery
Title
Functional outcomes Continence
Description
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.
Time Frame
3, 6 and 12 months after treatment.
Title
Functional outcomes Erection
Description
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.
Time Frame
3, 6 and 12 months after treatment.
Title
Functional outcomes Ejaculation
Description
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.
Time Frame
3, 6 and 12 months after treatment.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The trial is conducted on a population of males who underwent surgical intervention for prostate cancer.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerio Iacovelli, MD, PhD
Phone
+393398461654
Email
valerio.iacovelli85@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pierluigi Bove, MD
Email
pgbove@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierluigi Bove, MD
Organizational Affiliation
San Carlo di Nancy Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Carlo di Nancy Hospital
City
Roma
State/Province
RM
ZIP/Postal Code
00175
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerio Iacovelli, MD, PhD
Phone
+393398461654
Email
valerio.iacovelli85@gmail.com
First Name & Middle Initial & Last Name & Degree
Pierluigi Bove, MD
First Name & Middle Initial & Last Name & Degree
Chiara Cipriani, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The analysis of the data obtained within the trial will be subject of scientific publication
Citations:
PubMed Identifier
35528781
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.
Results Reference
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Transperineal Laser Ablation for Low- and Intermediate Risk Prostate Cancer: a Single Cohort Analysis

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