Prostate CancerPhase 2UnicornNCT04379362
MRI-guided Focal Laser Ablation
A Phase 2 study testing Focal laser ablation in people with Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Magnetic resonance imaging-guided focal laser ablation of prostate cancer. Read more about this study
- Who is it for?
- Ages 45 to 76 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal laser ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Dec 2018to 1 Jul 2024
- Phase
- Phase 2
- 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 ≤ 15 mm large axis;
- Life expectancy at inclusion of more 10 years;
- Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies;
- Criteria of low and intermediate risk of progression and eligibility for focal therapy (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 MRI signs of extra-capsular extension or invasion of the seminal vesicles;
- Maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI;
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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, 6500 HB
Annemarijke van Luijtelaar, MD, +31 (0)24 365 22 79, Annemarijke.vanLuijtelaar@radboudumc.nl
Joyce Bomers, PhD, +31 (0)24 365 22 79, Joyce.Bomers@radboudumc.nl
About this study
Official title: Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Focal laser ablation
- Keywords
- Focal laser ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal laser ablationProcedure or surgery
Focal laser ablation
| Study group | Role | What they receive |
|---|---|---|
| Low or intermediate grade prostate cancer | Experimental | Not described Receives: Procedure: Focal laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine incontinence incontinence
To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).
Measured: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Secondary outcomes (6)
Local cancer control
To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies.
Measured: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
International Prostate Symptom Score (IPSS)
To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. International Prostate Symptom Score (IPSS)
Measured: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)
To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)
Measured: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
International Consultation on Incontinence Questionnaire (ICIQ)
To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. the International Consultation on Incontinence Questionnaire (ICIQ).
Measured: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25
To evaluate quality of life before and after FLA in men with prostate cancer by using a validated quality of life questionnaire (EORTC QLQ PR25).
Measured: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
Complication rate
To evaluate the complication rate related to the technique
Measured: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start14 Dec 2018
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, interventional treatment, non-randomized, open label, single arm, phase II study with a medical device.
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biolitec Pharma Ltd., Soteria Medical, Siemens Corporation, Corporate Technology
- Responsible party
- Sponsor
- Investigators
- Jurgen Fütterer, MD, PhD, Principal investigator, Radboudumc NijmegenMichiel Sedelaar, MD, PhD, Principal investigator, Radboudumc Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379362
- Sponsor's protocol ID
- NL63647.091.17
- Acronym
- Unicorn
- Status last verified
- Sep 2021
- First submitted
- 23 Apr 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will be author of submitted manuscripts in case they fulfill criteria for authorship according to regulations of scientific journals. After scientific publication of the results the study protocol, relevant data and findings will be made publically available for other centers to implement (parts) of this research into their standard clinical practice if they wish to do so.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. 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
- NCT04379362
- Acronym / sponsor ID
- Unicorn / NL63647.091.17
- Conditions
- Prostate Cancer
- Keywords
- Focal laser ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Biolitec Pharma Ltd., Soteria Medical, Siemens Corporation, Corporate Technology
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 7 May 2020 (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.
Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, interventional treatment, non-randomized, open label, single arm, phase II study with a medical device.
| Arm | Type | Receives |
|---|---|---|
| Low or intermediate grade prostate cancer | Experimental | Procedure: 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 (6 listed)
- MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
- Maximum MRI visible lesion size is ≤ 15 mm large axis;
- Life expectancy at inclusion of more 10 years;
- Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies;
- Criteria of low and intermediate risk of progression and eligibility for focal therapy (clinical stage of maximum T2c, maximum biopsy Gleason score of 4 + 3 on targeted biopsies, serum prostate specific antigen < 15 ng/ml);
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 MRI signs of 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 ablationFocal laser ablation | Procedure or surgery | Low or intermediate grade prostate cancer |
Primary outcome
Urine incontinence incontinence
Time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).
6 secondary outcomes
Local cancer control
Time frame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
International Prostate Symptom Score (IPSS)
Time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)
Time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
International Consultation on Incontinence Questionnaire (ICIQ)
Time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25
Time frame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
Complication rate
Time frame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No. The investigators will be author of submitted manuscripts in case they fulfill criteria for authorship according to regulations of scientific journals. After scientific publication of the results the study protocol, relevant data and findings will be made publically available for other centers to implement (parts) of this research into their standard clinical practice if they wish to do so.
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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.
Jurgen Fütterer, MD, PhD principal investigator
Radboudumc Nijmegen
Michiel Sedelaar, MD, PhD principal investigator
Radboudumc Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Focal laser ablation in people with Prostate Cancer, 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 6 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 22 Sep 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Annemarijke van Luijtelaar, MD (+31 (0)24 365 22 79, Annemarijke.vanLuijtelaar@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine incontinence incontinence (time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.). 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 22 Sep 2021.