Trial Outcomes & Findings for Early Changes In Multiparametric MRI In Prostate Cancer (NCT NCT01959542)
NCT ID: NCT01959542
Last Updated: 2020-06-02
Results Overview
Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
2 months after starting ADT (Visit 1)
Results posted on
2020-06-02
Participant Flow
Participant milestones
| Measure |
Single Arm
All enrolled patients undergo PSA sampling and prostate MRI. No control arm.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
Evaluable at Visit 1
|
12
|
|
Overall Study
Evaluable at Visit 2
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Changes In Multiparametric MRI In Prostate Cancer
Baseline characteristics by cohort
| Measure |
MRIs and PSA Blood Test
n=12 Participants
* Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI
* Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI
* Visit 3 (on last day of EBRT): PSA blood test
* Visit 4 (6 months after starting ADT): PSA blood test and prostate MRI
MRI
PSA Blood Test: Serum PSA will also be subsequently checked on the same day as each follow-up MR is performed, i.e. TP 1, 2 and 3, and right after finishing EBRT. 1-2 mls of blood will be sampled per blood test.
Androgen Deprivation Therapy (ADT): Patients will receive ADT as part of their standard clinical care, as determined by their clinician.
External Beam Radiation Therapy (EBRT): Patients will receive EBRT as part of their standard clinical care, as determined by their clinician.
|
|---|---|
|
Age, Continuous
|
70.2 mean
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 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
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
baseline PSA
|
24.75 ng/ml
STANDARD_DEVIATION 32.01 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 months after starting ADT (Visit 1)Population: 12 patients enrolled. For one patient, data was not extracted from the MRI due to artifact.
Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA
Outcome measures
| Measure |
Single Arm
n=11 Participants
All enrolled patients undergo PSA sampling and prostate MRI. No control arm.
|
|---|---|
|
Correlation Between MRI Parameter at Visit 1 and Nadir PSA
|
-0.53 correlation coefficient
Interval -0.86 to 0.1
|
SECONDARY outcome
Timeframe: 6 weeks after starting EBRT (Visit 2)Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA
Outcome measures
| Measure |
Single Arm
n=12 Participants
All enrolled patients undergo PSA sampling and prostate MRI. No control arm.
|
|---|---|
|
Correlation Between MRI Parameter at Visit 2 With Nadir PSA
|
-0.62 Pearson correlation coefficient
Interval -0.88 to -0.08
|
Adverse Events
Single Arm
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. Fiona Fennessy
Brigham and Women's Hospital/Dana-farber Cancer Institute
Phone: 617 632 4891
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place