N/A N=60 Randomized Treatment

The Prostate Immobilization Device Study

Adenocarcinoma of the Prostate

Bottom Line

View on ClinicalTrials.gov: NCT01408706 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. — .319; .095 CENTIMETERS

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Miller Air tip (Device); Radiadyne Immobilizer (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: James Taylor
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.	.319; .095	—
SECONDARY Difficulty of Insertion.	1.083808; 1.067535	—
SECONDARY Patient Expression of Discomfort	1.138237; 1.087719	—

Summary

The purpose of this study is to compare reproducibility of the device position and location of the prostate rectum interface between two immobilization devices for radiation therapy of prostate carcinoma.

Eligibility Criteria

Inclusion Criteria

18 years of age or older
Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate
Planned definitive radiation therapy

Exclusion Criteria

Prior proctectomy
Rectal surgery within one year
Proctitis
Rectal carcinoma
Anal Stenosis
History of inflammatory bowel disease
Scleroderma
Systemic sclerosis
Refusal of treatment with immobilization device

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01408706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.