Prostate CancerNCT05584787
Transperineal Laser Ablation for Low- and Intermediate Risk Prostate Cancer: a Single Cohort Analysis
A study testing Soractelite Echolaser Transperineal focal laser ablation in people with Prostate Cancer, run by San Carlo di Nancy Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Soractelite Echolaser Transperineal focal laser ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with low- and intermediate risk prostate cancer classified as International Society for Urological Pathology, ISUP 1-2.
Who cannot join
- patients diagnosed with urothelial cancer
- contraindications for MRI
- Multifocal prostate cancer
Trial locations and contacts
1 site in 1 country.
Pierluigi Bove, MD contact
Italy1 site, 1 recruiting
- Recruiting
San Carlo di Nancy Hospital
Roma, RM, 00175
Valerio Iacovelli, MD, PhD, +393398461654, valerio.iacovelli85@gmail.com
Pierluigi Bove, MD
About this study
Official title: Transperineal Laser Ablation for Low and Intermediate Risk Prostate Cancer: a Single Cohort Analysis
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.
- Conditions
- Prostate Cancer
- Being tested
- Soractelite Echolaser Transperineal focal laser ablation
- Keywords
- prostate cancer, focal therapy, Echolaser, transperineal laser ablation, TPLA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soractelite Echolaser Transperineal focal laser ablationProcedure or surgery
US/MRI fusion laser ablation of low- and intermediate risk prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| TPLA in patients with prostate cancer | Experimental | Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy. Receives: Procedure: Soractelite Echolaser Transperineal focal laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after treatment
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.
Measured: 12 months after treatment
Oncological outcomes PSA
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Measured: 3 months after treatment.
Oncological outcomes PSA
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Measured: 6 months after treatment.
Oncological outcomes PSA
Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Measured: 12 months after treatment.
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.
Measured: 12 months after treatment
Secondary outcomes (5)
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.
Measured: 3, 6 and 12 months after treatment.
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).
Measured: day after surgery
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.
Measured: 3, 6 and 12 months after treatment.
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.
Measured: 3, 6 and 12 months after treatment.
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.
Measured: 3, 6 and 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 May 2021
- Primary completion29 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Carlo di Nancy Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Elesta S.R.L.
- Responsible party
- Sponsor
- Investigators
- Pierluigi Bove, MD, Principal investigator, San Carlo di Nancy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584787
- Sponsor's protocol ID
- TPLA K
- Status last verified
- Jan 2024
- First submitted
- 7 Oct 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The analysis of the data obtained within the trial will be subject of scientific publication
Publications
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.
PubMed 35528781
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transperineal Laser Ablation for Low and Intermediate Risk Prostate Cancer: a Single Cohort Analysis
- ClinicalTrials.gov ID
- NCT05584787
- Acronym / sponsor ID
- TPLA K
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, focal therapy, Echolaser, transperineal laser ablation, TPLA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- San Carlo di Nancy HospitalUniversity, hospital or other
- Collaborators
- Elesta S.R.L.
- Study start
- 1 May 2021 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPLA in patients with prostate cancer | Experimental | Procedure: Soractelite Echolaser Transperineal focal laser ablationPatients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with low- and intermediate risk prostate cancer classified as International Society for Urological Pathology, ISUP 1-2.
Key exclusion criteria (3 listed)
- patients diagnosed with urothelial cancer
- contraindications for MRI
- Multifocal prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soractelite Echolaser Transperineal focal laser ablationUS/MRI fusion laser ablation of low- and intermediate risk prostate cancer | Procedure or surgery | TPLA in patients with prostate cancer |
Primary outcome
Oncological outcomes MRI
Time frame: 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
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.
Oncological outcomes PSA
Time frame: 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
Time frame: 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
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.
5 secondary outcomes
Functional outcomes IPSS and IPSS QoL
Time frame: 3, 6 and 12 months after treatment.
Quality of life Pain
Time frame: day after surgery
Functional outcomes Continence
Time frame: 3, 6 and 12 months after treatment.
Functional outcomes Erection
Time frame: 3, 6 and 12 months after treatment.
Functional outcomes Ejaculation
Time frame: 3, 6 and 12 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Results publication: PubMed 35528781van 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.
- Individual participant dataSharing planned: No. The analysis of the data obtained within the trial will be subject of scientific publication
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierluigi Bove, MD contact
Pierluigi Bove, MD principal investigator
San Carlo di Nancy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soractelite Echolaser Transperineal focal laser ablation in people with Prostate Cancer, run by San Carlo di Nancy Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerio Iacovelli, MD, PhD (+393398461654, valerio.iacovelli85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncological outcomes MRI (time frame: 3 months after treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05584787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.