MRI Guided Prostate Cancer Focal Laser Ablation
Stopped early · Not applicable
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT03634579
- Run by
- Emory University
- People needed
- 9
- Starts
- 2018-06-01
- Expected to finish
- 2019-03-15
- Last updated by the study team
- 2020-03-23
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Emory University Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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