Prostate Neoplams, Magnetic Resonance Imaging, Laser AblationNCT05370482
MRI-guided Focal Laser Ablation Prostate Cancer
A study testing Focal laser ablation in people with Prostate Neoplams, Magnetic Resonance Imaging, Laser Ablation, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are gaining ground as a novel strategy to treat organ-confined low- to intermediate risk PCa while preserving healthy tissue… Read more about this study
- Who is it for?
- Ages 45 to 76 years, men only
- Conditions the study is for
- Prostate Neoplams, Magnetic Resonance Imaging, Laser Ablation
- What is being tested?
- Focal laser ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Apr 2022to 11 Apr 2025
- 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 45 to 76 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
- maximum MRI visible lesion size is ≤ 20 mm large axis;
- age 45 to 76 years old;
- life expectancy at inclusion of more 10 years;
- diagnosis of prostate cancer confirmed by targeted biopsy;
- criteria of low and intermediate risk of progression and eligibility for focal therapy;
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- clinical stage of maximum T2c
- maximum biopsy Gleason score of 4 + 3 on targeted biopsies
- serum prostate specific antigen < 15 ng/ml
- patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice.
Who cannot join
- History of prostate surgery;
- history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis;
- history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer);
- severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score > 18;
- tumor with extra-capsular extension or invasion of the seminal vesicles;
- patients with >2 lesions;
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- impossibility to obtain a valid informed consent;
- patients unable to undergo MR imaging, including those with contra-indications;
- contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection);
- metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging;
- patients with evidence for nodal or metastatic disease;
- patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Yvonne Wimper, Yvonne.Wimper@radboudumc.nl
About this study
Official title: Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are gaining ground as a novel strategy to treat organ-confined low- to intermediate risk PCa while preserving healthy tissue and reduce treatment-related morbidity associated with radical treatments.
This project has the goal to perform a feasibility study on magnetic resonance imaging (MRI)-guided focal laser ablation using the TRANBERG®|Thermoguide Therapy System including TRANBERG®Thermoguide Workstation for MR thermometry developed by the company CLS AB.
Read the detailed description
Prostate cancer is the most frequent non-cutaneous malignancy in the western male population, with almost 13,600 newly diagnosed patients in the Netherlands in 2019. Due to widespread use of the prostate-specific antigen (PSA) test and the lowered PSA threshold for biopsy, the number of newly diagnosed prostate cancers strongly increased in the last 20 years.
At present, treatment choice for prostate cancer patients at low or intermediate risk of disease progression lies between active surveillance (AS) and radical therapies, such as radical prostatectomy or radiotherapy. For these patients, radical treatments have a comparable effectiveness, with a risk of specific death of less than 1% in 15 years. However, none is devised of consequences on the quality of life and can induce significant morbidities such as incontinence and impotence.
For this reason, innovative ablation techniques such as cryosurgery, high intensity focused ultrasound, photodynamic therapy and laser ablation therapy have emerged and are increasingly applied in clinical practice. These treatment methods aim for local destruction of cancerous cells using various sources of energy. The main advantage of preservation of healthy prostatic tissue is to reduce treatment-related complications and morbidity. Recent studies demonstrate that post-treatment prognosis is predominantly driven by the largest lesion with the highest grade, the so-called 'index lesion'. Treatment approaches which preserve parts of the prostatic gland are considered as focal therapy. Imaging plays an important role in detection, localization, targeting and monitoring of focal prostate cancer treatment. Multi-parametric magnetic resonance imaging (mpMRI) is preferred in detecting and staging prostate cancer due to excellent soft tissue contrast and multiplanar anatomical imaging. It is also used to differentiate between post-treatment changes and potential recurrent or residual disease. As such, secondary treatment can be promptly established. More recently, mpMRI has gained acceptance in image-guided therapeutic settings since it offers real-time anatomical imaging in different planes and therefore improved treatment accuracy. Furthermore it can provide real-time temperature imaging.
Focal laser ablation (FLA) or laser-induced interstitial thermal therapy (LITT) is a relatively new technique which was originally developed to treat brain tumors. During this therapy, a laser fiber is positioned into the tumor under image guidance (ultrasound or MRI). When the position of the fiber is correct, laser light is delivered through the fiber and the temperature of the tissue around the tip of the fiber increases. When temperature increases above 60°C the tissue is irreversibly damaged and destroyed. The total ablation process takes about 2-3 minutes. MRI is perfectly suited to use for image guidance during FLA, because it can be used to localize the tumor, target it with probes, monitor and control the ablation procedure in real-time and to map tissue temperature.
Only a few studies on MRI-guided FLA are known. Lepor et al provided a pilot study of 25 patients with low-intermediate risk prostate cancer undergoing FLA. Three months after treatment, they showed no significant differences in functional outcome according to the SHIM (Sexual Health in Man) and AUASS (American Urological Association Symptom Score) questionnaires and no incontinence. Furthermore, 96% of the ablation zones targeted with biopsy three months after treatment, showed no histopathological prove of residual prostate cancer. A recent study by Walser et al. demonstrated a freedom of retreatment rate of 83% after a one year follow up in a group of 120 men with low- to intermediate risk disease that underwent transrectal FLA with no significant changes in quality of life or sexual and urinary function.
In Radboudumc we have several years of experience with MRI-guided focal laser ablation for prostate cancer treatment. At this moment separate systems are used for MR thermometry (IFE, Siemens) and laser energy control (Biolitec). CLS offers a dedicated system which integrates laser energy control with MR thermometry for ablation monitoring. Next to this, additional types of laser fibers are available that are thought to produce relatively larger, more adequate ablation zones (up to 3.0 x 2.0 cm) in comparison to current fibers. In potential, this will decrease the total procedure time because less ablations per lesion are needed and more patients will be eligible for FLA because larger tumors can be treated.
This project has the purpose to assess the feasibility of MRI-guided FLA treatment using the newly developed CLS system as well as its usability and safety.
- Being tested
- Focal laser ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal laser ablationDevice
MRI-guided focal laser ablation for prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided focal laser ablation | Experimental | Not described Receives: Device: Focal laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
completion of complete ablation without technical failures
completion of laser ablation without technical failures, achievement of complete ablation shown by MRI after treatment calculated using image co-registration software, total procedure time, total numver of fiber positions and ablations needed
Measured: 1 day
procedure-related adverse events and complications following SIR criteria
procedure-related adverse events and complications following SIR criteria
Measured: 6 months
Secondary outcomes (3)
tumor response
measured with MRI 6 months after treatment
Measured: 6 months
(local) progression free survival (PFS) at 6 months
measured with MRI
Measured: 6 months
incontinence en potency rate
according to IPSS and IIEF-5
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start11 Apr 2022
- Primary completion11 Oct 2023 (estimated)
- Study completion11 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Neoplams, Magnetic Resonance Imaging, Laser AblationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- CLS, Tranberg, Laser system
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jurgen Fütterer, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370482
- Sponsor's protocol ID
- 2021-13069
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05370482
- Acronym / sponsor ID
- 2021-13069
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 11 Oct 2023 (estimated)
- Study completion
- 11 Apr 2025 (estimated)
- First posted
- 11 May 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.
Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are gaining ground as a novel strategy to treat organ-confined low- to intermediate risk PCa while preserving healthy tissue and reduce treatment-related morbidity associated with radical treatments.
This project has the goal to perform a feasibility study on magnetic resonance imaging (MRI)-guided focal laser ablation using the TRANBERG®|Thermoguide Therapy System including TRANBERG®Thermoguide Workstation for MR thermometry developed by the company CLS AB.
Detailed description
Prostate cancer is the most frequent non-cutaneous malignancy in the western male population, with almost 13,600 newly diagnosed patients in the Netherlands in 2019. Due to widespread use of the prostate-specific antigen (PSA) test and the lowered PSA threshold for biopsy, the number of newly diagnosed prostate cancers strongly increased in the last 20 years.
At present, treatment choice for prostate cancer patients at low or intermediate risk of disease progression lies between active surveillance (AS) and radical therapies, such as radical prostatectomy or radiotherapy. For these patients, radical treatments have a comparable effectiveness, with a risk of specific death of less than 1% in 15 years. However, none is devised of consequences on the quality of life and can induce significant morbidities such as incontinence and impotence.
For this reason, innovative ablation techniques such as cryosurgery, high intensity focused ultrasound, photodynamic therapy and laser ablation therapy have emerged and are increasingly applied in clinical practice. These treatment methods aim for local destruction of cancerous cells using various sources of energy. The main advantage of preservation of healthy prostatic tissue is to reduce treatment-related complications and morbidity. Recent studies demonstrate that post-treatment prognosis is predominantly driven by the largest lesion with the highest grade, the so-called 'index lesion'. Treatment approaches which preserve parts of the prostatic gland are considered as focal therapy. Imaging plays an important role in detection, localization, targeting and monitoring of focal prostate cancer treatment. Multi-parametric magnetic resonance imaging (mpMRI) is preferred in detecting and staging prostate cancer due to excellent soft tissue contrast and multiplanar anatomical imaging. It is also used to differentiate between post-treatment changes and potential recurrent or residual disease. As such, secondary treatment can be promptly established. More recently, mpMRI has gained acceptance in image-guided therapeutic settings since it offers real-time anatomical imaging in different planes and therefore improved treatment accuracy. Furthermore it can provide real-time temperature imaging.
Focal laser ablation (FLA) or laser-induced interstitial thermal therapy (LITT) is a relatively new technique which was originally developed to treat brain tumors. During this therapy, a laser fiber is positioned into the tumor under image guidance (ultrasound or MRI). When the position of the fiber is correct, laser light is delivered through the fiber and the temperature of the tissue around the tip of the fiber increases. When temperature increases above 60°C the tissue is irreversibly damaged and destroyed. The total ablation process takes about 2-3 minutes. MRI is perfectly suited to use for image guidance during FLA, because it can be used to localize the tumor, target it with probes, monitor and control the ablation procedure in real-time and to map tissue temperature.
Only a few studies on MRI-guided FLA are known. Lepor et al provided a pilot study of 25 patients with low-intermediate risk prostate cancer undergoing FLA. Three months after treatment, they showed no significant differences in functional outcome according to the SHIM (Sexual Health in Man) and AUASS (American Urological Association Symptom Score) questionnaires and no incontinence. Furthermore, 96% of the ablation zones targeted with biopsy three months after treatment, showed no histopathological prove of residual prostate cancer. A recent study by Walser et al. demonstrated a freedom of retreatment rate of 83% after a one year follow up in a group of 120 men with low- to intermediate risk disease that underwent transrectal FLA with no significant changes in quality of life or sexual and urinary function.
In Radboudumc we have several years of experience with MRI-guided focal laser ablation for prostate cancer treatment. At this moment separate systems are used for MR thermometry (IFE, Siemens) and laser energy control (Biolitec). CLS offers a dedicated system which integrates laser energy control with MR thermometry for ablation monitoring. Next to this, additional types of laser fibers are available that are thought to produce relatively larger, more adequate ablation zones (up to 3.0 x 2.0 cm) in comparison to current fibers. In potential, this will decrease the total procedure time because less ablations per lesion are needed and more patients will be eligible for FLA because larger tumors can be treated.
This project has the purpose to assess the feasibility of MRI-guided FLA treatment using the newly developed CLS system as well as its usability and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CLS, Tranberg, Laser system
| Arm | Type | Receives |
|---|---|---|
| MRI-guided focal laser ablation | Experimental | Device: Focal laser ablation |
Who may qualify
- Ages
- 45 to 76 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
- maximum MRI visible lesion size is ≤ 20 mm large axis;
- age 45 to 76 years old;
- life expectancy at inclusion of more 10 years;
- diagnosis of prostate cancer confirmed by targeted biopsy;
Key exclusion criteria (12 listed)
- History of prostate surgery;
- history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis;
- history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer);
- severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score > 18;
- tumor with extra-capsular extension or invasion of the seminal vesicles;
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 |
|---|---|---|
| Focal laser ablationMRI-guided focal laser ablation for prostate cancer | Device | MRI-guided focal laser ablation |
Primary outcome
completion of complete ablation without technical failures
Time frame: 1 day
completion of laser ablation without technical failures, achievement of complete ablation shown by MRI after treatment calculated using image co-registration software, total procedure time, total numver of fiber positions and ablations needed
procedure-related adverse events and complications following SIR criteria
Time frame: 6 months
procedure-related adverse events and complications following SIR criteria
3 secondary outcomes
tumor response
Time frame: 6 months
(local) progression free survival (PFS) at 6 months
Time frame: 6 months
incontinence en potency rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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.
Jurgen Fütterer principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal laser ablation in people with Prostate Neoplams, Magnetic Resonance Imaging, Laser Ablation, run by Radboud University Medical Center at 1 site in Netherlands.
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 10 inclusion and 12 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 26 Oct 2022. 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 Netherlands. 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 Yvonne Wimper (+31243611111, Yvonne.Wimper@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
completion of complete ablation without technical failures (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2022.