Prostate CancerNCT02200809
MR-guided Focal Laser Ablation of the Prostate
A study testing MR-guided focal laser ablation in people with Prostate Cancer and MRI, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, MRI, Focal Laser Ablation
- What is being tested?
- MR-guided focal laser ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jul 2014to Dec 2019
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed and biopsy proven prostate cancer
- Intermediate risk patients (PSA <= 20 ng/mL, Gleason ≤ 7, T2b)
- No previous treatment for prostate cancer
- Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images
- Signed informed consent by patient
- Age 18 years or older
- Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)
Who cannot join
- 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
3 sites in 1 country.
Netherlands3 sites
Ziekenhuisgroep Twente
Hengelo, Overijssel
Radboud University Medical Center
Nijmegen, Gelderland, 6500 HB
Canisius Wilhelmina Hospital
Nijmegen, Gelderland
About this study
Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.
- Conditions
- Prostate Cancer, MRI, Focal Laser Ablation
- Being tested
- MR-guided focal laser ablation
- Keywords
- MR-guided therapy, Focal laser ablation, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided focal laser ablationDevice
| Study group | Role | What they receive |
|---|---|---|
| MR-guided focal laser ablation | Experimental | Not described Receives: Device: MR-guided focal laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.
Measured: 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2019
- Study completionDec 2019
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.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, Ziekenhuisgroep Twente
- Responsible party
- Sponsor
- Investigators
- Jurgen Futterer, MD, PhD, Principal investigator, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200809
- Sponsor's protocol ID
- 2010/185
- Status last verified
- Apr 2018
- First submitted
- 21 Jul 2014
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-guided Focal Laser Ablation of the Prostate
- ClinicalTrials.gov ID
- NCT02200809
- Acronym / sponsor ID
- 2010/185
- Conditions
- Prostate Cancer, MRI, Focal Laser Ablation
- Keywords
- MR-guided therapy, Focal laser ablation, Prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, Ziekenhuisgroep Twente
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-guided focal laser ablation | Experimental | Device: MR-guided focal laser ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed and biopsy proven prostate cancer
- Intermediate risk patients (PSA <= 20 ng/mL, Gleason ≤ 7, T2b)
- No previous treatment for prostate cancer
- Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images
- Signed informed consent by patient
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| MR-guided focal laser ablation | Device | MR-guided focal laser ablation |
Primary outcome
Disease free survival
Time frame: 36 months.
The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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.
Jurgen Futterer, MD, PhD principal investigator
Radboud University Nijmegen Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-guided focal laser ablation in people with Prostate Cancer and MRI, run by Radboud University Medical Center at 3 sites 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease free survival (time frame: 36 months.). 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 24 Apr 2020.