Functional MRI Use in Prostate Radiation Treatment Planning

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: MRI

• Registration Number: NCT01985932
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

This study is being done to evaluate the use of MRI during radiation treatment planning to identify areas of tumor within the prostate to aid in future treatment planning and targeting of prostate cancer. This study will be conducted at the University of Pennsylvania Health System. The study is projected to run for 18 months. Subjects will be male 18 or older with a prostate cancer diagnosis and treatment plansat the Department of Radiation Oncology.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-18
• Primary Completion: 2014-04
• Study Completion: 2015-12
• Results First Submitted: 2019-10-21
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Results First Posted: 2019-11-26
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Age 18 or older
• Male
• Biopsy proven prostate cancer without evidence of metastatic disease
• Planned definitive external beam RT with daily ERB and implanted Visicoil fiducial markers.
• Prior fMRI-ec documenting an IPL 25 mm2 in axial bidimensional diameter product, concordant with intraprostatic tumor location as documented on transrectal ultrasoundbiopsy
• Subject capable of giving informed consent for standard external beam RT and for the study.
• No current contraindication that would prevent MRI or gadolinium contrast.

Exclusion Criteria

• Metastatic disease
• Lack of fMRI-ec documeneting an IPL 25 mm2 in axial bidimensional product, concordant with intraprostatic tumor location as documented on transrectal untrasound biopsy
• Neoadjuvant androgen deprivation therapy greater than 10 weeks, defined from date of LHRH analog injection to date of fMRI-sim
• Contraindication that would prevent MRI or gadolinium contrast
• GFR 30 mL/min/1.73m2 per Crockoft-Gault formula.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional MRI	MRI	Subjects in this arm receive functional MRI during radiation therapy treatment planning.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States