Prostate CancerLITT or FLANCT02243033
Phase II Laser Focal Therapy of Prostate Cancer
An observational study of Prostate Cancer, run by HALO Diagnostics at 1 site in United States.
Trial summary
Target recruitment: 1000 subjects. The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years. Read more about this study
- Who is it for?
- Ages 45 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MR-guided laser focal therapy
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Nov 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with prostate cancer
Who may be able to join
- Treatment Naïve patients:
- Male, 45 years of age or older.
- Diagnosis of prostate adenocarcinoma.
- Clinical stage T1c or T2a.
- Gleason score of 7 (3+4 or 4+3) or less.
- Three or fewer biopsy cores with prostate cancer.
Show all 16Show fewer
- PSA density not exceeding 0.375.
- One, two, or three tumor suspicious regions identified on multiparametric MRI.
- Negative radiographic indication of extra-capsular extent.
- Karnofsky performance status of at least 70.
- Estimated survival of 5 years or greater, as determined by treating physician.
- Tolerance for anesthesia/sedation.
- Ability to give informed consent.
- At least 6 weeks since any previous prostate biopsy.
- MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.
- Salvage candidates will be accepted upon physician referral.
Who cannot join
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
- History of other primary non-skin malignancy within previous three years.
- Diabetes
- Smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
Desert Medical Imaging
Indian Wells, California, 92210
About this study
Official title: A Phase II Study to Evaluate Outpatient Magnetic Resonance Image-guided Laser Focal Therapy for Prostate Cancer, a 20-year Survival Study
Target recruitment: 1000 subjects. The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize that laser focal therapy can be used to achieve oncologic control in carefully selected patients.
MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses light to heat a target area to try to destroy cancerous cells.
Read more
The laser system that will be used is called the Visualase® Thermal Therapy System. This system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers. However; this study is the first time this system has been studied for use in the treatment of prostate cancer with a trans-rectal approach.
MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.
Read the detailed description
Laser-induced interstitial thermal therapy (LITT) is a novel form of controlled, targeted thermal ablation that may offer measurable advantages over other ablative therapies for focal prostate therapy. Because LITT is magnetic resonance (MR) compatible, it enables an imaging advantage over other surgical or ablation techniques that utilize transrectal ultrasound to target and monitor treatment. MR imaging provides excellent soft-tissue contrast and three-dimensional (3D) anatomical imaging in any arbitrary plane, which can help to improve treatment planning and targeting. Additionally, MR-based temperature monitoring allows real-time feedback during MRI-guided thermal therapy as both deposition of light energy and MR signal acquisition can be performed simultaneously without degradation in the MR signal. Also, being in the MR diagnostic environment allows use of post- treatment imaging to verify tissue damage. Because MR images clearly depict the prostate anatomy and the surrounding critical structures, MR imaging has been incorporated into planning for external- beam radiotherapy, brachytherapy, and other treatments of the prostate. In addition to these basic features, Multiparametric prostate MRI (mpMRI) may be used to identify regions of disease in the prostate and better target therapy.
In this study, the investigators propose to evaluate the efficacy of a novel, FDA-approved thermal therapy and feedback system (Visualase® Thermal Therapy System) for the treatment of biopsy confirmed and MR-imageable prostate lesions. This system has been used in humans for the treatment of brain, bone (spine), thyroid, and liver cancers. Early feasibility studies for prostate cancer used a transperineal approach; however it is now being evaluated for the primary treatment of prostate cancer using a transrectal approach. This system allows delivery of laser energy while the patient is simultaneously being imaged by an MRI unit. The system's real-time MR thermal imaging (MRTI) provides information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has previously not been possible with other ablative therapies. The investigators hypothesize the system can be integrated into a practical and feasible outpatient treatment paradigm for focal treatment of localized prostate cancer and allow patients to avoid the complications associated with radical whole-gland therapy.
- Conditions
- Prostate Cancer
- Being tested
- MR-guided laser focal therapy
- Keywords
- Prostate cancer, Focal therapy, Laser therapy, Transrectal, MRI-guided
- 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 laser focal therapyDevice
Also called Visualase, Tranberg
Placement of laser applicator under MRI guidance and real-time MR thermal imaging of tissue necrosis.
| Study group | Role | What they receive |
|---|---|---|
| Visualase | MR-guided laser focal therapy Receives: Device: MR-guided laser focal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events
Number of subjects reporting serious adverse events.
Measured: 1 yr. post treatment
Secondary outcomes (1)
Efficacy of treatment
MR-guided biopsy results of treated area and PSA.
Measured: 1 yr. post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMay 2016
- Primary completionMay 2036 (estimated)
- Study completionNov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HALO Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John F. Feller, MD, Principal investigator, HALO DiagnosticsBernadette M. Greenwood, MSc, Study director, HALO Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243033
- Sponsor's protocol ID
- DMI-Laser-001
- Other IDs
- WIRB Pr. No.: 20140945
- Acronym
- LITT or FLA
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2014
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication
Publications
Greenwood, B. et al.: Transrectal interventional MRI: initial prostate biopsy experience. SPIE Proceedings, 2010.
Hakimi AA, Feder M, Ghavamian R. Minimally invasive approaches to prostate cancer: a review of the current literature. Urol J. 2007 Summer;4(3):130-7.
PubMed 17987573Menon M, Tewari A, Peabody JO, Shrivastava A, Kaul S, Bhandari A, Hemal AK. Vattikuti Institute prostatectomy, a technique of robotic radical prostatectomy for management of localized carcinoma of the prostate: experience of over 1100 cases. Urol Clin North Am. 2004 Nov;31(4):701-17. doi: 10.1016/j.ucl.2004.06.011.
PubMed 15474597Valerio M, Emberton M, Ahmed HU. Focal therapy will become a standard option for selected men with localized prostate cancer. J Clin Oncol. 2014 Nov 10;32(32):3680-1. doi: 10.1200/JCO.2014.56.7792. Epub 2014 Aug 18. No abstract available.
PubMed 25135989
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate Outpatient Magnetic Resonance Image-guided Laser Focal Therapy for Prostate Cancer, a 20-year Survival Study
- ClinicalTrials.gov ID
- NCT02243033
- Acronym / sponsor ID
- LITT or FLA / DMI-Laser-001
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Focal therapy, Laser therapy, Transrectal, MRI-guided
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- HALO DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- May 2036 (estimated)
- Study completion
- Nov 2036 (estimated)
- First posted
- 17 Sep 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.
Target recruitment: 1000 subjects. The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize that laser focal therapy can be used to achieve oncologic control in carefully selected patients.
MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses light to heat a target area to try to destroy cancerous cells.
The laser system that will be used is called the Visualase® Thermal Therapy System. This system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers. However; this study is the first time this system has been studied for use in the treatment of prostate cancer with a trans-rectal approach.
MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.
Detailed description
Laser-induced interstitial thermal therapy (LITT) is a novel form of controlled, targeted thermal ablation that may offer measurable advantages over other ablative therapies for focal prostate therapy. Because LITT is magnetic resonance (MR) compatible, it enables an imaging advantage over other surgical or ablation techniques that utilize transrectal ultrasound to target and monitor treatment. MR imaging provides excellent soft-tissue contrast and three-dimensional (3D) anatomical imaging in any arbitrary plane, which can help to improve treatment planning and targeting. Additionally, MR-based temperature monitoring allows real-time feedback during MRI-guided thermal therapy as both deposition of light energy and MR signal acquisition can be performed simultaneously without degradation in the MR signal. Also, being in the MR diagnostic environment allows use of post- treatment imaging to verify tissue damage. Because MR images clearly depict the prostate anatomy and the surrounding critical structures, MR imaging has been incorporated into planning for external- beam radiotherapy, brachytherapy, and other treatments of the prostate. In addition to these basic features, Multiparametric prostate MRI (mpMRI) may be used to identify regions of disease in the prostate and better target therapy.
In this study, the investigators propose to evaluate the efficacy of a novel, FDA-approved thermal therapy and feedback system (Visualase® Thermal Therapy System) for the treatment of biopsy confirmed and MR-imageable prostate lesions. This system has been used in humans for the treatment of brain, bone (spine), thyroid, and liver cancers. Early feasibility studies for prostate cancer used a transperineal approach; however it is now being evaluated for the primary treatment of prostate cancer using a transrectal approach. This system allows delivery of laser energy while the patient is simultaneously being imaged by an MRI unit. The system's real-time MR thermal imaging (MRTI) provides information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has previously not been possible with other ablative therapies. The investigators hypothesize the system can be integrated into a practical and feasible outpatient treatment paradigm for focal treatment of localized prostate cancer and allow patients to avoid the complications associated with radical whole-gland therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visualase | – | Device: MR-guided laser focal therapyMR-guided laser focal therapy |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with prostate cancer
Key inclusion criteria (16 listed)
- Male, 45 years of age or older.
- Diagnosis of prostate adenocarcinoma.
- Clinical stage T1c or T2a.
- Gleason score of 7 (3+4 or 4+3) or less.
- Three or fewer biopsy cores with prostate cancer.
Key exclusion criteria (5 listed)
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
- History of other primary non-skin malignancy within previous three years.
- Diabetes
- Smoker
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 laser focal therapyAlso: Visualase, TranbergPlacement of laser applicator under MRI guidance and real-time MR thermal imaging of tissue necrosis. | Device | Visualase |
Primary outcome
Safety and adverse events
Time frame: 1 yr. post treatment
Number of subjects reporting serious adverse events.
1 secondary outcome
Efficacy of treatment
Time frame: 1 yr. post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- BackgroundGreenwood, B. et al.: Transrectal interventional MRI: initial prostate biopsy experience. SPIE Proceedings, 2010.
- Background: PubMed 17987573Hakimi AA, Feder M, Ghavamian R. Minimally invasive approaches to prostate cancer: a review of the current literature. Urol J. 2007 Summer;4(3):130-7.
- Background: PubMed 15474597Menon M, Tewari A, Peabody JO, Shrivastava A, Kaul S, Bhandari A, Hemal AK. Vattikuti Institute prostatectomy, a technique of robotic radical prostatectomy for management of localized carcinoma of the prostate: experience of over 1100 cases. Urol Clin North Am. 2004 Nov;31(4):701-17. doi: 10.1016/j.ucl.2004.06.011.
- Background: PubMed 25135989Valerio M, Emberton M, Ahmed HU. Focal therapy will become a standard option for selected men with localized prostate cancer. J Clin Oncol. 2014 Nov 10;32(32):3680-1. doi: 10.1200/JCO.2014.56.7792. Epub 2014 Aug 18. No abstract available.
- HALODxLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publication
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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.
John F. Feller, MD principal investigator
HALO Diagnostics
Bernadette M. Greenwood, MSc study director
HALO Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by HALO Diagnostics 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 16 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 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 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?
This study is still under way. Results are not available in the source record yet.
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 adverse events (time frame: 1 yr. post treatment). 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 NCT02243033, which also lists 4 linked publications.
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 25 Mar 2022.