NCT00770822

Brief Summary

This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined 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
466

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

6 active sites

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

April 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

13.3 years

First QC Date

October 9, 2008

Last Update Submit

April 9, 2019

Conditions

Prostate Cancer

Keywords

PrimaryProstateCancerPrimary T1c/T2a organ confined prostate cancerorgan-confined

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months.

    24 Months

Study Arms (2)

Device, HIFU

EXPERIMENTAL

High Intensity Focused Ultrasound

Device: HIFU (Sonablate® 500)

Device, brachytherapy

ACTIVE COMPARATOR

Brachytherapy

Device: Brachytherapy

Interventions

HIFU (Sonablate® 500)DEVICE

High Intensity Focused Ultrasound

Also known as: SB-500, Sonablate 500, HIFU
Device, HIFU
BrachytherapyDEVICE

Standard of care

Also known as: Raditation Seed Implants, Brachy
Device, brachytherapy

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T1c or T2a carcinoma of the prostate confirmed by biopsy;
  • life expectancy of 5(five) years or more;
  • prostate biopsy with 10(ten) or more core biopsies;
  • Gleason score of 6(six) or less;
  • serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less;
  • prostate volume of less than 40(Forty)cc;
  • distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less;
  • informed consent for the treatment study through 24 months post-treatment follow-up

You may not qualify if:

  • men who have had previous definitive treatment for prostate cancer;
  • evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years;
  • prior hormonal therapy for prostate cancer (including bilateral orchiectomy);
  • inability to tolerate a transrectal ultrasound;
  • active urinary tract infection;
  • functional bladder problems;
  • prior significant rectal surgery;
  • intra-prostatic calcifications greater than 1(One)cm in diameter;
  • interest in future fertility;
  • prostatic surgery/procedure (except biopsy) within 1(One) year;
  • large median lobe of the prostate;
  • use of medications that can affect PSA within 2(Two) months (e.g. finasteride, saw palmetto);
  • current bladder cancer, urethral stricture, or bladder neck contracture;
  • urinary tract and/or rectal fistula;
  • rectal fibrosis/stenosis;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Brachytherapy Site: Urology Centers of Alabama

Birmingham, Alabama, 35209, United States

Location

Brachytherapy Site: Specialists in Urology

Naples, Florida, 34102, United States

Location

Brachytherapy Site: Grand Strand Urology

Myrtle Beach, South Carolina, 29572, United States

Location

HIFU Site: Southeast Urology Network

Memphis, Tennessee, 38119, United States

Location

HIFU Site: Urology Associates

Nashville, Tennessee, 37209, United States

Location

HIFU Site: Urology of San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Mark Schoenberg, M.D.

    Johns Hopkins Medical Institution

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

April 1, 2007

Primary Completion

July 1, 2020

Study Completion

December 1, 2020

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

US(6)