NCT03632980

Brief Summary

Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
6.5 years until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

8.5 years

First QC Date

January 31, 2012

Last Update Submit

August 13, 2018

Conditions

Cancer of Prostate

Keywords

HIFULocalized Prostate cancerMRIPSA nadirBiopsyHigh Intensity Focused UltrasoundProstate Specific Antigen (PSA)

Outcome Measures

Primary Outcomes (1)

  • Necrosis measurement (immediate efficacy)

    The coagulation necrosis induced by the HIFU dynamic focusing treatment of the prostate is evaluated by MRI in the first week post treatment.

    Day 7

Secondary Outcomes (11)

  • Histological marker measurement (mid term efficacy)

    6 months

  • Biochemical marker measurement (mid term efficacy)

    6 months

  • Rectal wall preservation (immediate safety and morbidity)

    Day 7

  • Adverse events reporting rates (safety and the morbidity) at 6 months

    6 months

  • Adverse events reporting rates (safety and the morbidity) at 24 months

    24 months

  • +6 more secondary outcomes

Study Arms (1)

HIFU prostate treatment

EXPERIMENTAL

The HIFU intervention will concern Primary care patients or Secondary care patients (salvage). Intervention with "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment devices HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - First line" to Patients suffering from localized prostate cancer that has not been previously treated or Salvage HIFU intervention will be administered with "Ablatherm Foc/Dyn or Focal One - Post radiotherapy" to subjects harboring prostate cancer recurrency after radiotherapy

Device: "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment

Interventions

"Ablatherm Foc/Dyn" or "Focal One" HIFU treatmentDEVICE

Non invasive treatment of localized prostate cancer by High Intensity Focused Ultrasound therapy, endorectal application. or Non invasive treatment of localized prostate cancer recurrency by High Intensity Focused Ultrasound therapy after radiotherapy failure, endorectal application.

Also known as: Ablatherm Foc/Dyn or Ablatherm Foc/Dyn post-radiotherapy, Focal One or Focal One post-radiotherapy, First line treatment or Salvage treatment post-radiotherapy
HIFU prostate treatment

Eligibility Criteria

Age70 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \> 70 years
  • T1 or T2
  • PSA \< 15 ng/mL
  • randomized biopsies
  • Gleason score ≤ 3+4
  • Normal anal and rectal anatomy
  • American Society of Anesthesiologists risk (ASA) 1 or 2

You may not qualify if:

  • T3 patients
  • American Society of Anesthesiologists risk (ASA) 3
  • Metastatic disease (Bone scan…)
  • Previous prostate cancer therapy
  • Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness
  • Prostate volume over 50cc
  • Previous bladder cancer
  • contraindication to MRI
  • previous rectal or urinary fistulae
  • Age \> 50 years
  • T1 or T2
  • Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml)
  • randomized biopsies
  • Normal anal and rectal anatomy
  • ASA 1 or 2
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edouard Herriot Hospital

Lyon, 69003, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Albert GELET, MD

    Edouard Herriot Hospital, Lyon, France

    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

January 31, 2012

First Posted

August 16, 2018

Study Start

June 1, 2011

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

FR(1)