Prostate Immobilization Device Used During Radiation Trea... | NCT00114985

Studies
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

NCT00114985

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

May 3, 2023Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

Prostate Immobilization Device

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

Jan 2005Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jun 20, 2005

First Submission Date that Met QC Criteria

Jun 20, 2005

First Posted Date

Jun 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2023

Last Update Posted Date

May 3, 2023Actual

Name	Class
Brigham and Women's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.

Detailed Description

MRI using an endorectal coil done prior to treatment for staging.
Baseline Quality of Life (QOL) assessment will be completed prior to treatment.
Total androgen suppression is initiated and will continue for at least 6 months.
Prostate Immobilization Device (PID) placed during the planning session.
PID will be placed daily for the first 15 3D external beam radiation treatments.
QOL assessment and follow-up will take place every 6 months for 3 years.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prostate Immobilization Device	Device	Device placed during radiation treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rectal toxicity at six month intervals		2 years

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life		2 years
urinary symptoms		2 years
sexual dysfunction at six month intervals

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy proven prostate cancer
Clinical Stage T1 - T4
Negative bone scan
PSA and routine blood work
>30 years of age
ECOG Performance 0,1, or 2
No prior pelvic radiation
No pacemaker

Exclusion Criteria:

Inflammatory bowel disease (Crohns, or Ulcerative Colitis)
Prostatic rectal fistula
Stricture of anal canal

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

31 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony V. D'Amico, MD, PhD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15890580	Background	Woel R, Beard C, Chen MH, Hurwitz M, Loffredo M, McMahon E, Ching J, Lopes L, D'Amico AV. Acute gastrointestinal, genitourinary, and dermatological toxicity during dose-escalated 3D-conformal radiation therapy (3DCRT) using an intrarectal balloon for prostate gland localization and immobilization. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):392-6. doi: 10.1016/j.ijrobp.2004.10.003.

ID	Term
D011471	Prostatic Neoplasms
D006471	Gastrointestinal Hemorrhage

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms