Functional MRI Use in Prostate Radiation Treatment Planning

Prostate Cancer Clinical Trial

Official title:

A Prospective Study Evaluating Non-Endorectal Coil Functional MRI Identification of Intraprostatic Tumor During Radiation Treatment Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985932
• Other study ID #: UPCC 07812
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• MRI

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		2 years