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 using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events.
Active, not recruiting
N/A
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 investigational laser-based interstitial irradiation/thermal soft-tissue ablation
system. Safety and feasibility will be determined by analyzing the number, type, and severity
of adverse events. In addition, changes in health-related quality of life (HRQOL) will be
evaluated using Expanded Prostate Index Composite for Clinical Practice (EPIC-CP), Memorial
Anxiety Scale for Prostate Cancer (MAX-PC), and Decision Regret Scale.
This is an open-label early feasibility/pilot study to evaluate the safety and feasibility of
the Orion System. In this study, the investigators intend to use the investigational Orion
system to deploy and monitor thermal energy in cancerous regions of the prostate, identified
by MRI and confirmed by targeted biopsy. MRI guidance will be achieved by MRI/ultrasound
fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser
treatments would be achieved by inserting the fiber into the cancerous regions guided by the
Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be
used to treat the target region. Subjects will return to clinic 1 week, 1 month, and every 3
months until one year post-FLA to be monitored for adverse events and complete Health Related
Quality of Life (HRQOL) questionnaires. Biomarker (PSA) kinetics will also be monitored.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Focal Laser Ablation | Experimental | The Orion system will be used to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy. |
Inclusion Criteria:
- 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 Criteria:
- 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)
| Maximum Eligible Age: | 85 Years |
| Minimum Eligible Age: | 40 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
| Measure: | Safety based on cumulative adverse events incurred |
| Time Frame: | From treatment at 1 week, 1 month, and every 3 months until one year. |
| Safety Issue: | |
| Description: | Safety will be determined by the cumulative number, type, and severity of adverse events incurred by subjects. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Jonsson Comprehensive Cancer Center |
December 4, 2020
