Prostate CancerNCT05826470
Investigator Initiated Trial to Further Evaluate the Safety and Efficacy of Trans-perineal Focal Laser Ablation of Localized Prostate Cancer Using High Frequency Micro-ultrasound Imaging
A study testing TRANBERG®|Thermal Therapy System in people with Prostate Cancer and Low-risk or Favorable Intermediate Risk Prostate Cancer Who Are on an Active Surveillance Regimen, run by Genesis Research LLC at 1 site in United States.
Trial summary
Trans-perineal focal laser ablation represents a promising alternative focal therapy option for patients with low-risk or favorable intermediate risk prostate cancer. FLA has been extensively utilized for over a decade in the treatment of PCa using different anatomical approaches. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Low-risk or Favorable Intermediate Risk Prostate Cancer Who Are on an Active Surveillance Regimen
- What is being tested?
- TRANBERG®|Thermal Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 5 Dec 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men between the ages of 40 and 85 years
- Ability to read, understand and agree/sign the patient informed consent in the English language.
- Serum PSA < 20 ng/ml
- AJCC clinical tumor stage T2b or less (according to digital rectal examination)
- Men with localized PCa (GG 1or 2, Gleason Score 7 or less) (Low or Favorable Intermediate Risk PCa) with an MR-image detected index lesion done within three months from the time of enrollment and visible on micro-ultrasound
- According to the decision of the investigator:
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- Patient is suitable to undergo treatment with FLA
- Able to tolerate a procedure under local anesthesia
- Able to undergo Nitrous Oxide sedation
- Able to undergo MR
- has normal rectal anatomy
- Lesion Specificity:
- Unilateral, with cumulative lesion volumes not comprising more than 50 percent of the lobe as determined by MRI
- Lesion distances from the outer perimeter of the energy emitting zone of the diffuser to adjacent vital structures (bladder wall, rectal wall, neurovascular bundles, and urethra) must be ≥ 8mm
- Minimum distance to rectal wall and other sensitive structures ≥ 8mm
Who cannot join
- Previous prostate surgery
- Patients with recurrent prostate cancer
- Anticoagulant therapy
- Gleason Grade Group 3 PCa or higher
- Multifocal PCa other than Gleason Grade Group 1
- Locally advanced or metastatic PCa
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- Prior or ongoing PCa treatment including surgery, radiation therapy, hormonal therapy or focal therapy
- Previous radiation of the pelvic region
- Intraprostatic calculus > 5mm
- Inability to tolerate a dorsal lithotomy position under Nitrous Oxide sedation for > 90 minutes
- ECOG Status ≥2
- Urethral Stenosis
- Prostate height > 5 cm anterior to posterior or a prostate volume >100 cc's
Trial locations and contacts
1 site in 1 country.
About this study
Trans-perineal focal laser ablation represents a promising alternative focal therapy option for patients with low-risk or favorable intermediate risk prostate cancer. FLA has been extensively utilized for over a decade in the treatment of PCa using different anatomical approaches. The proposed study differs from past ones in that a trans-perineal approach with reduced risk of infection will be used in contrast to the current trans-rectal approach. In addition, high frequency micro-ultrasound imaging will be used to enhance imaging and facilitate accurate needle placement and FLA of the index lesions.
The aim of this study is to evaluate FLA as a potential optimal therapeutic intervention based on safety, ease of use, efficacy, and cost.1 FLA holds promise for the management of localized tumors. The combination of the trans-perineal focal laser ablation and micro-ultrasound imaging will enable targeted trans-perineal fusion laser induced thermal therapy of prostate cancer lesions. This approach offers significant potential advantages over traditional interventions including:
- Improved dynamic ultrasound imaging of the lesion to be treated compared to traditional ultrasound techniques.
- Enhanced ability to visualize and spare critical structures within the prostate, including the bladder neck, neurovascular bundle (NVB), urethral sphincter and organs in close proximity including the rectum.
- Sparing these structures should translate into improved preservation of ejaculation, limited changes in sexual function and minimal transient incontinence following treatment.
Read the detailed description
Device: TRANBERG® Transperineal Micro Ultrasound guided laser ablation of Prostate Cancer A perineal local anesthesia block is performed with the patient in lithotomy. The micro-ultrasound, secured to a digital stepper, is inserted and advanced. The live ultrasound image is displayed on the micro-ultrasound machine. The urologist advances the laser fiber introducer, temperature probes, and laser fiber to desired positions in the prostate using micro-ultrasound guidance. One laser fiber will be used for single or multiple treatment applications.
Target treatment is achieved once the laser applicator position is confirmed. The urologist will instruct on the desired treatment parameters to be entered into the TRANBERG® console. Real-time monitoring of the ablation zone will be done using the micro-ultrasound and temperature probes. Once the individual treatment has been completed, the applicator will be relocated to the next location, if necessary. Patients will be discharged home with instructions and contact information once stable.
Primary Outcome Measures:
The primary objective of this study is to assess the safety \& tolerability of a tandem approach using micro-ultrasound imaging for FLA in patients with organ confined localized low or favorable intermediate risk Prostate Cancer.
The secondary objectives are to evaluate the efficacy of FLA in ablating the index tumor lesion, as well as clinical outcomes: erectile and sexual function as well as urinary control. In addition, volumetric changes in prostate lesions, prostate size as well as cancer control in treated areas will be assessed by both imaging (mpMRI) and pathology (prostate needle biopsy). Additional secondary objectives include:
- Determine the presence or absence of csPCa in the index lesion ablation zone (in- treatment field) at the 12 month post procedure biopsy.
- Evaluate the ability of high frequency micro-ultrasound imaging to identify the mpMRI. detected index lesion in the prostate.
- Evaluate the ability of micro-ultrasound to image the index lesion ablation size and compare ablation sizes using post procedure MRI.
- Determine the cost-benefit effectiveness of the treatment with trans-perineal focal laser ablation in office treatment under local anesthesia supplement with Nitrous Oxide sedation.
- Evaluate duration of treatment using trans-perineal focal laser ablation.
- Conditions
- Prostate Cancer, Low-risk or Favorable Intermediate Risk Prostate Cancer Who Are on an Active Surveillance Regimen
- Being tested
- TRANBERG®|Thermal Therapy System
- Keywords
- Prostate Cancer, Laser, Focal Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRANBERG®|Thermal Therapy SystemDevice
Focal laser ablation.
| Study group | Role | What they receive |
|---|---|---|
| Laser Ablation | Experimental | TRANBERG® Transperineal Micro Ultrasound guided laser ablation of Prostate Cancer. Receives: Device: TRANBERG®|Thermal Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Number of Adverse Events Related to the Treatment
AE and SAE will be evaluated during all visits using the CTCAE scale. Grade 3 or greater AEs based on the CTCAE v5.0 within 5 days post procedure will be considered severe and related to the study procedure.
Measured: 12 months
Secondary outcomes (1)
Efficacy: Extent of Tumor Ablation by Laser Application
To evaluate the efficacy of FLA in ablating the index tumor lesion, as well as clinical outcomes: erectile and sexual function and urinary control. Volumetric changes in prostate lesions, prostate size and cancer control in treated areas assessed by mpMRI and prostate needle biopsy. Determine the presence or absence of csPCa in the index lesion ablation zone at the 12 month post procedure biopsy. Evaluate the ability of high frequency micro-ultrasound imaging to identify the mpMRI detected index lesion in the prostate. Evaluate the ability of micro-ultrasound to image the index lesion ablation size and compare ablation sizes using post procedure MRI. Evaluate duration of treatment using trans-perineal focal laser ablation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start30 May 2023
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Why it stopped: Business decision of the Sponsor
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genesis Research LLC
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826470
- Sponsor's protocol ID
- UNIO-2023-001
- Status last verified
- Dec 2024
- First submitted
- 23 Mar 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kayano PP, Klotz L. Current evidence for focal therapy and partial gland ablation for organ-confined prostate cancer: systematic review of literature published in the last 2 years. Curr Opin Urol. 2021 Jan;31(1):49-57. doi: 10.1097/MOU.0000000000000838.
PubMed 33196540
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Trial to Further Evaluate the Safety and Efficacy of Trans-perineal Focal Laser Ablation of Localized Prostate Cancer Using High Frequency Micro-ultrasound Imaging
- ClinicalTrials.gov ID
- NCT05826470
- Acronym / sponsor ID
- UNIO-2023-001
- Conditions
- Prostate Cancer, Low-risk or Favorable Intermediate Risk Prostate Cancer Who Are on an Active Surveillance Regimen
- Keywords
- Prostate Cancer, Laser, Focal Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision of the Sponsor
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Genesis Research LLCResearch network
- Study start
- 30 May 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 24 Apr 2023 (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.
Trans-perineal focal laser ablation represents a promising alternative focal therapy option for patients with low-risk or favorable intermediate risk prostate cancer. FLA has been extensively utilized for over a decade in the treatment of PCa using different anatomical approaches. The proposed study differs from past ones in that a trans-perineal approach with reduced risk of infection will be used in contrast to the current trans-rectal approach. In addition, high frequency micro-ultrasound imaging will be used to enhance imaging and facilitate accurate needle placement and FLA of the index lesions.
The aim of this study is to evaluate FLA as a potential optimal therapeutic intervention based on safety, ease of use, efficacy, and cost.1 FLA holds promise for the management of localized tumors. The combination of the trans-perineal focal laser ablation and micro-ultrasound imaging will enable targeted trans-perineal fusion laser induced thermal therapy of prostate cancer lesions. This approach offers significant potential advantages over traditional interventions including:
- Improved dynamic ultrasound imaging of the lesion to be treated compared to traditional ultrasound techniques.
- Enhanced ability to visualize and spare critical structures within the prostate, including the bladder neck, neurovascular bundle (NVB), urethral sphincter and organs in close proximity including the rectum.
- Sparing these structures should translate into improved preservation of ejaculation, limited changes in sexual function and minimal transient incontinence following treatment.
Detailed description
Device: TRANBERG® Transperineal Micro Ultrasound guided laser ablation of Prostate Cancer A perineal local anesthesia block is performed with the patient in lithotomy. The micro-ultrasound, secured to a digital stepper, is inserted and advanced. The live ultrasound image is displayed on the micro-ultrasound machine. The urologist advances the laser fiber introducer, temperature probes, and laser fiber to desired positions in the prostate using micro-ultrasound guidance. One laser fiber will be used for single or multiple treatment applications.
Target treatment is achieved once the laser applicator position is confirmed. The urologist will instruct on the desired treatment parameters to be entered into the TRANBERG® console. Real-time monitoring of the ablation zone will be done using the micro-ultrasound and temperature probes. Once the individual treatment has been completed, the applicator will be relocated to the next location, if necessary. Patients will be discharged home with instructions and contact information once stable.
Primary Outcome Measures:
The primary objective of this study is to assess the safety \& tolerability of a tandem approach using micro-ultrasound imaging for FLA in patients with organ confined localized low or favorable intermediate risk Prostate Cancer.
The secondary objectives are to evaluate the efficacy of FLA in ablating the index tumor lesion, as well as clinical outcomes: erectile and sexual function as well as urinary control. In addition, volumetric changes in prostate lesions, prostate size as well as cancer control in treated areas will be assessed by both imaging (mpMRI) and pathology (prostate needle biopsy). Additional secondary objectives include:
- Determine the presence or absence of csPCa in the index lesion ablation zone (in- treatment field) at the 12 month post procedure biopsy.
- Evaluate the ability of high frequency micro-ultrasound imaging to identify the mpMRI. detected index lesion in the prostate.
- Evaluate the ability of micro-ultrasound to image the index lesion ablation size and compare ablation sizes using post procedure MRI.
- Determine the cost-benefit effectiveness of the treatment with trans-perineal focal laser ablation in office treatment under local anesthesia supplement with Nitrous Oxide sedation.
- Evaluate duration of treatment using trans-perineal focal laser ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Ablation | Experimental | Device: TRANBERG®|Thermal Therapy SystemTRANBERG® Transperineal Micro Ultrasound guided laser ablation of Prostate Cancer. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men between the ages of 40 and 85 years
- Ability to read, understand and agree/sign the patient informed consent in the English language.
- Serum PSA < 20 ng/ml
- AJCC clinical tumor stage T2b or less (according to digital rectal examination)
- Men with localized PCa (GG 1or 2, Gleason Score 7 or less) (Low or Favorable Intermediate Risk PCa) with an MR-image detected index lesion done within three months from the time of enrollment and visible on micro-ultrasound
Key exclusion criteria (13 listed)
- Previous prostate surgery
- Patients with recurrent prostate cancer
- Anticoagulant therapy
- Gleason Grade Group 3 PCa or higher
- Multifocal PCa other than Gleason Grade Group 1
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 |
|---|---|---|
| TRANBERG®|Thermal Therapy SystemFocal laser ablation. | Device | Laser Ablation |
Primary outcome
Safety and Tolerability: Number of Adverse Events Related to the Treatment
Time frame: 12 months
AE and SAE will be evaluated during all visits using the CTCAE scale. Grade 3 or greater AEs based on the CTCAE v5.0 within 5 days post procedure will be considered severe and related to the study procedure.
1 secondary outcome
Efficacy: Extent of Tumor Ablation by Laser Application
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Business decision of the Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 33196540Kayano PP, Klotz L. Current evidence for focal therapy and partial gland ablation for organ-confined prostate cancer: systematic review of literature published in the last 2 years. Curr Opin Urol. 2021 Jan;31(1):49-57. doi: 10.1097/MOU.0000000000000838.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRANBERG®|Thermal Therapy System in people with Prostate Cancer and Low-risk or Favorable Intermediate Risk Prostate Cancer Who Are on an Active Surveillance Regimen, run by Genesis Research LLC at 1 site in United States.
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 15 inclusion and 13 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: stopped early, as of the sponsor's last update on 10 Dec 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 United States. 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?
The study was stopped early (reason given: Business decision of the Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: Number of Adverse Events Related to the Treatment (time frame: 12 months). 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 NCT05826470, 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 Dec 2024.