NCT00318240

Brief Summary

This is a feasibility study to determine safety and the ability of HIFU (High Intensity Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local recurrence of prostate cancer following radiation treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

April 24, 2006

Last Update Submit

August 25, 2017

Conditions

Prostate Cancer

Keywords

High Intensity Focused UltrasoundMenLocally recurrent prostate cancer.

Outcome Measures

Primary Outcomes (1)

  • To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.

    ongoing

Secondary Outcomes (2)

  • Destruction of prostate cancer tissue.

    ongoing

  • Safety of repeating procedure in patients who do not respond adequately.

    ongoing

Study Arms (1)

1

EXPERIMENTAL

High Intensity Focused

Device: High Intensity Focused Ultrasound

Interventions

High Intensity Focused UltrasoundDEVICE

Treatment of Radiation failure in Prostate Cancer

Also known as: HIFU
1

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • · Male patients with an initial presentation of organ confined recurrent prostate cancer (clinical Stages T1 and T2 only) who have been treated with external beam radiation therapy or brachytherapy and subsequently has biopsy-proven local recurrence.
  • Age \> 40 years through \<80 years.
  • Anesthesia Surgical Assignment (ASA) categories I, II or III only.
  • Negative radionuclide bone scan within 3 months prior to HIFU treatment to rule out the possibility of metastases.
  • PSA levels \>0.5ng/ml and \<10ng/ml.
  • Pre-radiation Gleason score \< 8
  • Clearly imageable prostate on TRUS
  • Written informed consent.

You may not qualify if:

  • · T3 or T4 prostate cancer.
  • Age \<40 years. or \>80 years.
  • ASA of IV and higher.
  • Gleason score\>8.
  • PSA \<0.5ng/ml or \>10ng/ml.
  • Prostate size \> 40 grams as determined by transrectal ultrasound
  • Large calcification in the area to be treated (\>5mm).
  • Bleeding disorder as determined by abnormal prothrombin time (INR)and partial thromboplastin time (PTT).
  • Patient on Coumadin or any other anticoagulant, unless their anticoagulation can be temporarily reversed or stopped.
  • Urinary tract infection unless treated satisfactorily by antibiotics and documented by a sterile urine culture.
  • Interest in future fertility.
  • History of allergy to latex.
  • Inability to visualize the prostatic tissue adequately on transrectal ultrasound imaging.
  • Currently on hormonal therapy for prostate cancer (patients can be enrolled if they come off hormone therapy for 3 months).
  • History of treatment for prostate cancer, other than brachytherapy or external beam radiation.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

MeSH Terms

Conditions

Prostatic NeoplasmsMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Dr. Joseph Chin

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 26, 2006

Study Start

April 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

CA(1)