Trial Outcomes & Findings for Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning (NCT NCT02470910)

NCT ID: NCT02470910

Last Updated: 2019-12-11

Results Overview

The volume of rectum receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: within 1 year of MRI examination
• Results posted on: 2019-12-11

Participant Flow

Participant milestones

Measure	Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning

Baseline characteristics by cohort

Measure	Magnetic Resonance Imaging n=15 Participants MRI examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy Magnetic Resonance Imaging
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: within 1 year of MRI examination

The volume of rectum receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans.

Outcome measures

Measure	MRI-based Planning n=15 Participants A radiation therapy plan was designed using MRI-defined prostate volume. Median volume of rectum receiving 70Gy or more was calculated from the dose-volume histogram.	CT-based Planning n=15 Participants A radiation therapy plan was designed using CT-defined prostate volume. Median volume of rectum receiving 70Gy or more was calculated from the dose-volume histogram.
Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.	4.9 cubic centimeters Interval 4.1 to 8.7	9.3 cubic centimeters Interval 7.0 to 10.2

SECONDARY outcome

Timeframe: within 1 year of MRI examination

The volume of bladder receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans.

Outcome measures

Measure	MRI-based Planning n=15 Participants A radiation therapy plan was designed using MRI-defined prostate volume. Median volume of rectum receiving 70Gy or more was calculated from the dose-volume histogram.	CT-based Planning n=15 Participants A radiation therapy plan was designed using CT-defined prostate volume. Median volume of rectum receiving 70Gy or more was calculated from the dose-volume histogram.
Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.	9.6 cubic centimeters Interval 8.2 to 12.9	12.7 cubic centimeters Interval 10.8 to 15.0

Adverse Events

Magnetic Resonance Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony D'Amico

DFCI/BWH

Phone: 8572151489

Email: adamico@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place