Trial Outcomes & Findings for Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients (NCT NCT03180398)

NCT ID: NCT03180398

Last Updated: 2023-10-12

Results Overview

Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

2 years

Results posted on

2023-10-12

Participant Flow

Participant milestones

Participant milestones
Measure
Multi-parametric MRI for Prostate Cancer
MRI will be acquired for prostate cancer patients undergoing radiation treatment. Multiparametric MRI: MRI will be acquired before, during and after radiation treatment to evaluate treatment response
Overall Study
STARTED
9
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Multi-parametric MRI for Prostate Cancer
n=9 Participants
MRI will be acquired for prostate cancer patients undergoing radiation treatment. Multiparametric MRI: MRI will be acquired before, during and after radiation treatment to evaluate treatment response
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
5 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
9 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
8 Participants
n=5 Participants
Race (NIH/OMB)
White
1 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
9 participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Radiomics requires sufficient patient number. Not enough patients were included for radiomics analyses. PI left institution and country. The data was not collected so analysis could not be completed.

Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Population: The patient number was too small for the planned radiomics analysis. The study was closed. The data was not collected so analysis could not be completed. PI left institution and country. Analysis could not be completed.

Tumor response as measured by an increase in PSA.

Outcome measures

Outcome data not reported

Adverse Events

Multi-parametric MRI for Prostate Cancer

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

Dr. Stephen Brown

Henry Ford Health

Phone: 3135858415

Results disclosure agreements

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