Low Grade Prostate CancerNCT01192438
Laser Based Focal Ablation of Low Grade Prostate Cancer
A study testing Laser-based thermotherapy in people with Low Grade Prostate Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Low Grade Prostate Cancer
- What is being tested?
- Laser-based thermotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2011
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, 45 years of age or older
- Diagnosis of prostate adenocarcinoma
- Clinical stage T1c or T2a
- Gleason score of 7 or less
- A minimum of 12 biopsy cores sampled during diagnostic biopsy
- Three or fewer biopsy cores with prostate cancer
Show all 11Show fewer
- No single biopsy core with greater than 50% of tumor involvement
- A radiographically visible prostate lesion on MRI with concordance to biopsy sextant
- A documented Karnofsky performance status of at least 70
- Estimated survival of 20 years or greater, as determined by treating physician
- Ability to give informed consent
Who cannot join
- Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
- History of previous pelvic radiation
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
- History of other primary non-skin malignancy within previous three years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer
The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.
- Conditions
- Low Grade Prostate Cancer
- Being tested
- Laser-based thermotherapy
- Keywords
- prostate, cancer, ablation, laser-induced, focal therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-based thermotherapyProcedure or surgery
Also called Visualase, Inc
MRI-guided transperineal placement of a laser probe into the prostate
| Study group | Role | What they receive |
|---|---|---|
| Procedure/surgery | Experimental | Not described Receives: Procedure: Laser-based thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: Within 6 months of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Visualase, Inc.
- Responsible party
- Sponsor
- Investigators
- Scott E Eggener, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192438
- Sponsor's protocol ID
- 09-364A
- Status last verified
- Mar 2014
- First submitted
- 27 Aug 2010
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer
- ClinicalTrials.gov ID
- NCT01192438
- Acronym / sponsor ID
- 09-364A
- Conditions
- Low Grade Prostate Cancer
- Keywords
- prostate, cancer, ablation, laser-induced, focal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Visualase, Inc.
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Sep 2010 (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.
The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure/surgery | Experimental | Procedure: Laser-based thermotherapy |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male, 45 years of age or older
- Diagnosis of prostate adenocarcinoma
- Clinical stage T1c or T2a
- Gleason score of 7 or less
- A minimum of 12 biopsy cores sampled during diagnostic biopsy
Key exclusion criteria (5 listed)
- Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
- History of previous pelvic radiation
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
- History of other primary non-skin malignancy within previous three years
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-based thermotherapyAlso: Visualase, IncMRI-guided transperineal placement of a laser probe into the prostate | Procedure or surgery | Procedure/surgery |
Primary outcome
Number of patients with adverse events
Time frame: Within 6 months of the procedure
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 Mar 2014.
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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.
Scott E Eggener, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser-based thermotherapy in people with Low Grade Prostate Cancer, run by University of Chicago 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 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: finished, as of the sponsor's last update on 27 Mar 2014. 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 patients with adverse events (time frame: Within 6 months of the procedure). 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 27 Mar 2014.