MRI Guided Prostate Cancer Focal Laser Ablation
| Status: | Suspended |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/22/2019 |
| Start Date: | June 1, 2018 |
| End Date: | July 2020 |
Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation of Localized Prostate Cancer
The study is a prospective, single-arm, non-randomized, unblinded trial to determine the
safety and efficacy of MRI guided focal laser ablation of localized low and intermediate risk
prostate cancer. All subjects meeting the inclusion exclusion criteria and are enrolled will
undergo a MRI guided focal laser ablation procedure. The primary aim of the study is to study
the safety and efficacy of the procedure.
safety and efficacy of MRI guided focal laser ablation of localized low and intermediate risk
prostate cancer. All subjects meeting the inclusion exclusion criteria and are enrolled will
undergo a MRI guided focal laser ablation procedure. The primary aim of the study is to study
the safety and efficacy of the procedure.
Prostate cancer should be viewed as a spectrum of diseases ranging from a very indolent
low-risk process to an aggressive high-risk potentially fatal disease. Active surveillance
has been introduced as an alternative treatment to patients with low- risk prostate
cancers.Focal therapy techniques have been introduced in prostate cancer to destroy the tumor
itself with adequate safety margin with the advantage of preserving the surrounding
non-cancerous tissue. Thus maintaining disease control at acceptable levels, while minimizing
complications.
With the advent of multiparametric MRI (Mp-MRI), it is now possible to identify suspicious
prostate gland focal lesions, determining their extent and targeting them for biopsy and
focal ablation. Laser interstitial thermal therapy (LITT) is well suited for MRI environment.
Laser fibers are flexible so they can fit into the MRI gantry. Laser has been shown to
produce homogenous tissue necrosis that can be monitored by real time temperature maps, a
feature that facilitates effective and safe ablation.
20 subjects with localized low and intermediate risk prostate cancer that meet the inclusion
and exclusion criteria will be enrolled. During baseline evaluation, subjects will undergo
lab tests, MR imaging, and will complete QOL questionnaires. Subsequently, subjects will
undergo the Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation
procedure. Subjects will be followed immediately after the procedure, at 3 weeks, 3 months, 6
months, one year and two years after procedure for adverse events and recurrence of prostate
cancer
low-risk process to an aggressive high-risk potentially fatal disease. Active surveillance
has been introduced as an alternative treatment to patients with low- risk prostate
cancers.Focal therapy techniques have been introduced in prostate cancer to destroy the tumor
itself with adequate safety margin with the advantage of preserving the surrounding
non-cancerous tissue. Thus maintaining disease control at acceptable levels, while minimizing
complications.
With the advent of multiparametric MRI (Mp-MRI), it is now possible to identify suspicious
prostate gland focal lesions, determining their extent and targeting them for biopsy and
focal ablation. Laser interstitial thermal therapy (LITT) is well suited for MRI environment.
Laser fibers are flexible so they can fit into the MRI gantry. Laser has been shown to
produce homogenous tissue necrosis that can be monitored by real time temperature maps, a
feature that facilitates effective and safe ablation.
20 subjects with localized low and intermediate risk prostate cancer that meet the inclusion
and exclusion criteria will be enrolled. During baseline evaluation, subjects will undergo
lab tests, MR imaging, and will complete QOL questionnaires. Subsequently, subjects will
undergo the Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation
procedure. Subjects will be followed immediately after the procedure, at 3 weeks, 3 months, 6
months, one year and two years after procedure for adverse events and recurrence of prostate
cancer
Inclusion Criteria:
- Age ≥18 years
- Patients with primary organ confined prostate cancer (≤T2c) and Gleason score ≤4+3=7
- Lesions visible on multiparametric MRI and subsequently diagnosed by targeted MRI
guided biopsy
Exclusion Criteria:
- Multifocal intra-prostatic disease, defined as the presence the presence of ≥ 3 non-
contiguous pathologically proven foci of cancer.
- Gleason score >4+3=7.
- Extracapsular spread.
- Nodal or distant metastasis
- Contraindications to MRI or general anesthesia.
- Uncorrectable Coagulopathy.
- Refusal of participation.
- Lesions not visualized on the multiparametric MRI
We found this trial at
1
site
1364 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 712-2000
Phone: 404-788-3164
Emory University Hospital As the largest health care system in Georgia and the only health...
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