Prostate CancerEarly Phase 1FLANCT02357121
Focal Laser Ablation of Prostate Tissue
A Early Phase 1 study testing Focal Laser Ablation in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- 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
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Sep 2015to 20 Aug 2019
- Phase
- Early Phase 1
- 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
- Subjects with untreated organ confined prostate cancer (clinical stage ≤ T2b, Gleason ≤ 3+4)
- Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA >10
- Age 40 years to 85 years of age
- Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a
- Region of interest (ROI) of MRI suspicion level 3 or higher
- MRI-calculated prostate volume 25cc to 100cc
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- Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI
- Histologically-confirmed adenocarcinoma from targeted biopsy cores
- Overall Gleason score not to exceed 3+4
- Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
- Signed informed consent for the FLA treatment through the 12 month follow up visit.
Who cannot join
- Any significant cancer outside of MRI target (ROI) area, defined as Gleason score > 3+4
- < 10 years life expectancy
- American Society of Anesthesiologists (ASA) criteria of IV or higher
- Unfit for conscious sedation anesthesia
- Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
- Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
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- Active urinary tract infection
- Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
- Any prior treatment for prostate cancer
- Radical prostatectomy
- Radiation therapy (external beam or brachytherapy)
- Cryotherapy
- High intensity focused ultrasound treatment
- Photodynamic therapy
- Androgen deprivation therapy
- Prior prostate, bladder neck, or urethral stricture surgery
- Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization
- Transurethral incision of bladder neck
- Urethral stricture dilation or reconstruction
- Any current 5-alpha reductase inhibitors (history of use ≥ 3 months prior to MRI is acceptable)
- Prior significant rectal surgery (hemorrhoidectomy is acceptable)
- Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
- Inflammatory bowel disease
- Urinary tract or rectal fistula
- Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA
Los Angeles, California, 90095
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance
This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Intra-procedure temperature and concurrent rectal wall thermistor monitoring will be performed for internal validation. Subjects will be monitored for adverse events, and health-related quality of life (HRQOL) questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be monitored.
- Conditions
- Prostate Cancer
- Being tested
- 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 AblationDevice
Also called laser treatment
Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance
| Study group | Role | What they receive |
|---|---|---|
| Laser ablation | Experimental | All patient will undergo focal ablation of prostate tissue utilizing laser energy. Receives: Device: Focal Laser Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of focal laser treatment using LITT: Number of participants with adverse events
Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.
Measured: 12 months
Secondary outcomes (1)
Efficacy of focal laser ablation of prostate tissue using the LITT system.
MRI changes will be determined at 6 and 12 months post FLA to assess efficacy.
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 posted6 Feb 2015 (estimated)
- Study start17 Sep 2015
- Primary completion20 Aug 2019
- Study completion20 Aug 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 Jonsson Comprehensive Cancer 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jean Perkins Foundation, Medtronic
- Responsible party
- Sponsor
- Investigators
- Leonard Marks, MD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357121
- Sponsor's protocol ID
- 15-000018
- Other IDs
- JCCCID534
- Acronym
- FLA
- Status last verified
- Apr 2020
- First submitted
- 28 Jan 2015
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance
- ClinicalTrials.gov ID
- NCT02357121
- Acronym / sponsor ID
- FLA / 15-000018
- Conditions
- Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Jean Perkins Foundation, Medtronic
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 6 Feb 2015 (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.
This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Intra-procedure temperature and concurrent rectal wall thermistor monitoring will be performed for internal validation. Subjects will be monitored for adverse events, and health-related quality of life (HRQOL) questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be monitored.
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: Focal Laser AblationAll patient will undergo focal ablation of prostate tissue utilizing laser energy. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects with untreated organ confined prostate cancer (clinical stage ≤ T2b, Gleason ≤ 3+4)
- Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA >10
- Age 40 years to 85 years of age
- Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a
- Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI
Key exclusion criteria (25 listed)
- Any significant cancer outside of MRI target (ROI) area, defined as Gleason score > 3+4
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 AblationAlso: laser treatmentFocal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance | Device | Laser ablation |
Primary outcome
safety of focal laser treatment using LITT: Number of participants with adverse events
Time frame: 12 months
Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.
1 secondary outcome
Efficacy of focal laser ablation of prostate tissue using the LITT system.
Time frame: 12 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 21 Sep 2020.
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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.
Leonard Marks, MD principal investigator
University of California at Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Focal Laser Ablation in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites 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 11 inclusion and 25 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
safety of focal laser treatment using LITT: Number of participants with adverse events (time frame: 12 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 21 Sep 2020.