Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer

NCT02968784 | Terminated

• 1 other identifier: PCa006
• Study Type: interventional
• Target: 53
• Locations: 3 countries
• Sites: 4

Brief Summary

This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can significantly postpone or eliminate the need of patients with organ confined intermediate risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation therapy) for their disease.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; MRgFUS; ExAblate; Focused Ultrasound

Outcome Measures

Primary Outcomes (2)

• The primary efficacy endpoint in this trial measured with whole-gland extended imaging-guided mapping biopsy, is Response scored dichotomously; success vs. failure

  Response will be based on mapping biopsy defined by Gleason 7 Score in any part of the prostate gland

  24 months post treatment

• Adverse events

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  24 months post treatment

Secondary Outcomes (5)

• Percent of patients with negative biopsy

  5 months post treatment

• Quality of Life - urinary symptoms - IPSS questionnaire score

  24 months post treatment

• Quality of Life - urinary continence - ICIQ-SF questionnaire score

  24 months post treatment

• Quality of Life - sexual function - IIEF-15 questionnaire score

  24 months

• Prostate Specific Antigen (PSA)

  24 months post treatment

Study Arms (1)

ExAblate MRgFUS

EXPERIMENTAL

Up to 50% of the prostate gland will be treated. Treatment will include the Index lesion which is visible on MRI + tumor free margins of 3-mm; tumor free margins will not extend beyond the posterior aspect of the prostate capsule. Urethral and bilateral neurovascular bundle preservation will be preferred whenever clinically justified. Additional foci in the same hemisphere that are confirmed by biopsy and are \< Gleason Score 7 (up to 3+4 or 4+3) or suspected to be positive for malignancy based on multi parametric-MRI) will also be included in the treated volume, providing total treatment volume does not exceed 50% of the gland.

Device: ExAblate MRgFUS

Interventions

ExAblate MRgFUS DEVICE

ExAblate treatment of prostate cancer less than or equal to Grade 7

Also known as: Focused Ultrasound

ExAblate MRgFUS

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSA ≤ 20 ng/ml
• Histologically proven PCa on imaging-guided transrectal or transperineal extended mapping biopsy
• Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on wtachful waiting or active surveillance and not in need of imminent therapy
• Gleason Score 7 (3+4 or 4+3) based on mapping prostate biopsy with no more than 15mm cancer in maximal linear dimension in any single core
• Single hemilateral index Gleason 7 lesion identified in the prostate based on biopsy mapping with supporting MRI findings; may have secondary Gleason 6 lesion on ipisilateral or contralateral side confirmed with biopsy and/or MRI

You may not qualify if:

• Any Contraindication to MRI, such as: over-size limitations avoiding patient's positioning in the bore of MRI scanner, claustrophobia, implanted ferromagnetic materials or foreign objects, or known contraindication to utilization of MRI contrast agent (e.g., Gadolinium/Magnevist)
• History of prostatectomy, radiation therapy to the pelvis for any other malignancy, brachytherapy, Cryotherapy, US-guided HIFU, orchiectomy, prostate photodynamic therapy, or prostate cancer-specific chemotherapy
• Patient under androgen deprivation therapy (ADT), alpha reductase inhibitors, and/or other hormonal treatment within the past 6 months
• Any rectal disease, pathology, anomaly, injury, previous treatment, or scarring which could change acoustic properties of the rectal wall, or might prevent safe probe insertion (e.g., inflammatory bowel disease, fistula, stenosis, fibrosis, or symptomatic hemorrhoids
• History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years
• Existing urethral or bladder neck contracture/stricture
• Prostatitis NIH categories I, II and III
• Implant near (\<1cm) the prostate

Sponsors & Collaborators

• InSightec: lead

Study Sites (4)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

Location

St. Mary's Hospital

London, W2 INY, United Kingdom

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

• Sangeet Ghai, MD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: November 21, 2016
• Study Start: June 1, 2016
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: May 9, 2023

Record last verified: 2020-07

Locations

GB (1); CA (1); CN (2)