Focal Laser Ablation of Prostate Cancer

NCT04305925 | Completed Early Phase 1 DMC FDA Device

• 2 other identifiers: 18-0015025R01CA218547
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer

Keywords

prostrate; ablation

Outcome Measures

Primary Outcomes (1)

• Safety based on cumulative adverse events incurred

  Safety will be determined by the cumulative number, type, and severity of adverse events incurred by subjects.

  From treatment at 1 week, 1 month, and every 3 months until one year.

Study Arms (1)

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.

Device: Focal Laser Ablation

Interventions

Focal Laser Ablation DEVICE

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.

Focal Laser Ablation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: eligibility based on physical existence of prostate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Allan Pantuck, M.D.

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label early feasibility/pilot study to evaluate the safety and feasibility of the focal laser ablation (FLA) Orion System. Men with histologically confirmed, non-metastatic, prostate adenocarcinoma, clinical stage ≤ T2b, with Gleason score 7 by MRI-ultrasound fusion targeted biopsy, without history of prior treatment and without neoadjuvant radiation or hormone therapy, who desire focal treatment with laser ablation will be enrolled.

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 12, 2020
• Study Start: January 30, 2020
• Primary Completion: January 30, 2023
• Study Completion: April 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)