NCT02243033Active, not recruiting
Phase II Laser Focal Therapy of Prostate Cancer
A Phase II Study to Evaluate Outpatient Magnetic Resonance Image-guided Laser Focal Therapy for Prostate Cancer, a 20-year Survival Study
Source: ClinicalTrials.gov · Last updated 25 Mar 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 9 Sept 2014
- Start date
- May 2016
- Primary completion date
- May 2036
- Lead sponsor
- HALO Diagnostics
- Diseases
- Prostate cancer
- NCT number
- NCT02243033
What you commit to
- Study type: Observational
- Planned participants: 1000
- From May 2016 to the primary completion date, May 2036
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of other primary non-skin malignancy within previous three years.
Other illness
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- Diabetes
Other
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
- Smoker
Who the study is looking for
- 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.
- 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.
Age in the registry: 45 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Desert Medical Imaging Coordinator of this site? Confirm its status | Indian Wells | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.