Prostate CancerLITTNCT02224911
Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer
An observational study of Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as well as 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?
- Laser Interstitial Thermal Therapy
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2014to 21 Oct 2019
- Phase
- Observational
- 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
Study population: Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion technology.
Who may be able to join
- Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤ T2b)
- 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
- ROI located proximal to the external sphincter by a margin of at least 2 cm
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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 (≥ 2 cores)
- Overall Gleason score not to exceed 3+4
- Subjects desire focal therapy and declined conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
- Signed informed consent for the LITT 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 ≥ 6 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
- History of inflammatory bowel disease
- Urinary tract or rectal fistula
- Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study
This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as well as to gather data for the design of future studies.
- Conditions
- Prostate Cancer
- Being tested
- Laser Interstitial Thermal Therapy
- Keywords
- focal therapy, prostate cancer treatment, laser treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Interstitial Thermal TherapyDevice
| Study group | Role | What they receive |
|---|---|---|
| Laser Interstitial Thermal Therapy | This is a minimally invasive procedure for focal treatment of prostate cancer. Receives: Device: Laser Interstitial Thermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Measured: 12 months
Secondary outcomes (1)
Absence of prostate cancer in the MRI target area as measure of 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 posted25 Aug 2014 (estimated)
- Study start11 Sep 2014
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pantuck Alan, MD, Principal investigator, University of California, Los AngelesSteven Raman, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224911
- Sponsor's protocol ID
- 14-000409
- Other IDs
- JCCCID436, NCI-2015-01487
- Acronym
- LITT
- Status last verified
- Feb 2020
- First submitted
- 21 Jul 2014
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
PubMed 23335087Carter HB, Kettermann A, Warlick C, Metter EJ, Landis P, Walsh PC, Epstein JI. Expectant management of prostate cancer with curative intent: an update of the Johns Hopkins experience. J Urol. 2007 Dec;178(6):2359-64; discussion 2364-5. doi: 10.1016/j.juro.2007.08.039. Epub 2007 Oct 22.
PubMed 17936806
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT02224911
- Acronym / sponsor ID
- LITT / 14-000409
- Conditions
- Prostate Cancer
- Keywords
- focal therapy, prostate cancer treatment, laser treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 Sep 2014 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 25 Aug 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.
This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as well as to gather data for the design of future studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Interstitial Thermal Therapy | – | Device: Laser Interstitial Thermal TherapyThis is a minimally invasive procedure for focal treatment of prostate cancer. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion technology.
Key inclusion criteria (11 listed)
- Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤ T2b)
Key exclusion criteria (25 listed)
- 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
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 |
|---|---|---|
| Laser Interstitial Thermal Therapy | Device | Laser Interstitial Thermal Therapy |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 12 months
1 secondary outcome
Absence of prostate cancer in the MRI target area as measure of efficacy.
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 27 Jul 2020.
- Background: PubMed 23335087Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
- Background: PubMed 17936806Carter HB, Kettermann A, Warlick C, Metter EJ, Landis P, Walsh PC, Epstein JI. Expectant management of prostate cancer with curative intent: an update of the Johns Hopkins experience. J Urol. 2007 Dec;178(6):2359-64; discussion 2364-5. doi: 10.1016/j.juro.2007.08.039. Epub 2007 Oct 22.
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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.
Pantuck Alan, MD principal investigator
University of California, Los Angeles
Steven Raman, MD principal investigator
University of California, Los Angeles
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 Jonsson Comprehensive Cancer Center 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 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 27 Jul 2020. 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?
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?
Number of participants with adverse events as a measure of safety and tolerability (time frame: 12 months). 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 NCT02224911, which also lists 2 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 27 Jul 2020.