Status:
ACTIVE_NOT_RECRUITING
Focal Laser Ablation of Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Phase:
EARLY_PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety and feasibility of Magnetic-Resonance(MR)-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer u...
Detailed Description
The primary objective is to evaluate the safety and feasibility of MR-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investig...
Eligibility Criteria
Inclusion
- Subjects with untreated, organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7) x Age 40 to 85 years of age
- Multi-parametric MRI at University of California at Los Angeles (UCLA) within 6 months of study treatment, demonstrating a Region of interest (ROI) of MRI (PIRADSv2 \> Grade 3). x Prostate volume 20cc to 80cc
- Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 targeted biopsy cores from above MRI-derived ROI within 6 month of biopsy results
- Histologically-confirmed adenocarcinoma from targeted biopsy cores x Overall Gleason = 3+4 or 4+3
- Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
- Signed informed consent for the FLA treatment through the 12 month follow-up
Exclusion
- Any significant cancer outside of the intended treatment zone, defined as Gleason score 7 x \< 10 years life expectancy
- Any medical condition that would compromise the subject's ability to safely ● Active bleeding disorder
- 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
- Active urinary tract infection x Active prostate abscess, prostatitis, or neurogenic bladder x Any prior treatment for prostate cancer, including:
- Radical prostatectomy
- Radiation therapy (external beam or brachytherapy)
- Cryotherapy
- High intensity focused ultrasound (HIFU) treatment o Photodynamic therapy o 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 x Urethral stricture dilation or reconstruction
- Use of 5-alpha reductase inhibitors within 6 months of treatment x Prior significant rectal surgery (hemorrhoidectomy is acceptable)
- Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
- Inflammatory bowel disease x Urinary tract or rectal fistula x Previous urethral sling, artificial urinary sphincter or penile prosthesis surgery.
- Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis, MRI-unsafe aneurysm clips)
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04305925
Start Date
January 30 2020
End Date
October 31 2026
Last Update
May 13 2025
Active Locations (1)
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1
University of California at Los Angeles
Los Angeles, California, United States, 90024