Trial Outcomes & Findings for A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer (NCT NCT01858688)
NCT ID: NCT01858688
Last Updated: 2023-05-03
Results Overview
The classification sensitivity of multiparametric endorectal magnetic resonance imaging (MP-erMRI) when compared to the standard of care procedure (transrectal ultrasound-guided (TRUS) re-biopsy) The sensitivity is equivalent to the proportion of patients who were reclassified by MP- erMRI out of the total number of patients who should have been reclassified (given their TRUS re-biopsy result). In other words, it is the proportion of participants reclassified appropriately by MP- erMRI.
COMPLETED
NA
101 participants
From baseline biopsy to final biopsy, up to 18 months
2023-05-03
Participant Flow
September 2013 - May 2017
Participant milestones
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
Biopsied at Baseline
|
97
|
|
Overall Study
MRI Assessed
|
91
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Participant began another therapy
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Progressive Disease
|
2
|
|
Overall Study
Reason not reproted
|
5
|
Baseline Characteristics
A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=97 Participants
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Performance Status
0 - Fully Active
|
87 Participants
n=5 Participants
|
|
Performance Status
1 - Restricted
|
1 Participants
n=5 Participants
|
|
Performance Status
Missing
|
9 Participants
n=5 Participants
|
|
Prostate-Specific Antigen Titer
|
4.6 ng/mL
n=5 Participants
|
|
Clinical Stage
T1a
|
0 Participants
n=5 Participants
|
|
Clinical Stage
T1b
|
0 Participants
n=5 Participants
|
|
Clinical Stage
T1c
|
83 Participants
n=5 Participants
|
|
Clinical Stage
T2a
|
11 Participants
n=5 Participants
|
|
Clinical Stage
T2b
|
0 Participants
n=5 Participants
|
|
Clinical Stage
T2c
|
0 Participants
n=5 Participants
|
|
Clinical Stage
T3
|
0 Participants
n=5 Participants
|
|
Clinical Stage
T4
|
0 Participants
n=5 Participants
|
|
Clinical Stage
Missing
|
3 Participants
n=5 Participants
|
|
Adult Comorbidity Evaluation Index
None
|
23 Participants
n=5 Participants
|
|
Adult Comorbidity Evaluation Index
Mild
|
30 Participants
n=5 Participants
|
|
Adult Comorbidity Evaluation Index
Moderate
|
27 Participants
n=5 Participants
|
|
Adult Comorbidity Evaluation Index
Severe
|
2 Participants
n=5 Participants
|
|
Adult Comorbidity Evaluation Index
Unknown
|
15 Participants
n=5 Participants
|
|
Computerized Tomography (CT) of Abdomen and Pelvis
Yes
|
6 Participants
n=5 Participants
|
|
Computerized Tomography (CT) of Abdomen and Pelvis
No
|
91 Participants
n=5 Participants
|
|
CT Bone Scan
Yes
|
3 Participants
n=5 Participants
|
|
CT Bone Scan
No
|
94 Participants
n=5 Participants
|
|
Gleason Score
3+3
|
97 Participants
n=5 Participants
|
|
Gleason Score
Missing
|
0 Participants
n=5 Participants
|
|
Evidence of Perineural Invasion
Yes
|
4 Participants
n=5 Participants
|
|
Evidence of Perineural Invasion
No
|
92 Participants
n=5 Participants
|
|
Evidence of Perineural Invasion
Missing
|
1 Participants
n=5 Participants
|
|
Extracapsular Extension
Yes
|
0 Participants
n=5 Participants
|
|
Extracapsular Extension
No
|
93 Participants
n=5 Participants
|
|
Extracapsular Extension
Missing
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline biopsy to final biopsy, up to 18 monthsPopulation: Population that completed all treatment interventions.
The classification sensitivity of multiparametric endorectal magnetic resonance imaging (MP-erMRI) when compared to the standard of care procedure (transrectal ultrasound-guided (TRUS) re-biopsy) The sensitivity is equivalent to the proportion of patients who were reclassified by MP- erMRI out of the total number of patients who should have been reclassified (given their TRUS re-biopsy result). In other words, it is the proportion of participants reclassified appropriately by MP- erMRI.
Outcome measures
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=81 Participants
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
MP-erMRI Classification Sensitivity
|
0.875 proportion of true positives
Interval 0.656 to 0.977
|
PRIMARY outcome
Timeframe: From baseline biopsy to final biopsy, up to 18 monthsPopulation: Population that completed all treatment interventions.
The classification specificity of multiparametric endorectal magnetic resonance imaging (MP-erMRI) when compared to the standard of care procedure (transrectal ultrasound-guided (TRUS) re-biopsy) The specificity is equivalent to the proportion of patients who were not reclassified by MP- erMRI out of the total number of patients who should have been not reclassified (given their TRUS re-biopsy result). In other words, it is the proportion of participants not reclassified appropriately by MP- erMRI.
Outcome measures
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=81 Participants
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
MP- erMRI Classification Specificity
|
0.785 proportion of true negatives
Interval 0.684 to 0.865
|
SECONDARY outcome
Timeframe: From baseline biopsy to final MRI, up to 18 monthsPopulation: The population that underwent MRI
The frequency of reclassification using MP- erMRI, given in the form of a percentage of participants who have been reclassified.
Outcome measures
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=90 Participants
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Frequency of Reclassification
|
40 percentage of participants
Interval 31.3 to 49.2
|
SECONDARY outcome
Timeframe: From baseline biopsy to final MRI, up to 18 monthsPopulation: Baseline and post-study questionnaire data available for 48 participants.
The median change from baseline in illness-related uncertainty, anxiety, and distress measured by The Mishel Uncertainty in Illness Scale Community Form for Active Surveillance (MUIS-AS). The questionnaire entails 15 parts scored from 0-4 for a total of 0-60. The higher the score, the worse the symptoms of uncertainty, anxiety, and distress.
Outcome measures
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=48 Participants
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Median Change in Illness-Related Uncertainty, Anxiety, and Distress
|
-2 score on a scale
Interval -27.0 to 12.0
|
SECONDARY outcome
Timeframe: From baseline biopsy to final MRI, up to 18 monthsPopulation: Baseline and post-study questionnaire data available for 47 participants.
The median change from baseline in service satisfaction measured by Services Satisfaction Scale - for Cancer Care (SSS-Ca). The questionnaire entails 5 parts scored from 1-7 for a total of 7-35. The higher the score, the more dissatisfied the participant.
Outcome measures
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=47 Participants
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Median Change in Service Satisfaction
|
0 change in score
Interval -9.0 to 19.0
|
SECONDARY outcome
Timeframe: From baseline biopsy to final MRI, up to 18 monthsPopulation: Baseline and post-study questionnaire data available for 47 participants.
The median change from baseline in prostate cancer symptoms measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP). The questionnaire entails 15 parts scored from 0-4 for a total of 0-60. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=47 Participants
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Median Change in Prostate Cancer Symptoms
|
0 change in score
Interval -6.0 to 9.8
|
SECONDARY outcome
Timeframe: From baseline biopsy to final MRI, up to 18 monthsPopulation: Baseline and post-study questionnaire data available for 49 participants. Only 46 participants have complete data for question 8.
The median change from baseline in urinary symptoms measured by the American Urological Association Symptoms Index (AUA SI). The questionnaire entails 8 parts. Parts 1-7 are scored 0-5 (for a total scoring range of 0-35) and part 8, a question evaluating psychological effect is scored from 0-6. The higher the score, the worse the participant's symptoms.
Outcome measures
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=49 Participants
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Median Change in Urinary Symptoms
Urinary Symtoms
|
0 change in score
Interval -7.0 to 10.0
|
|
Median Change in Urinary Symptoms
Psychological Effect
|
0 change in score
Interval -2.0 to 2.0
|
SECONDARY outcome
Timeframe: From baseline biopsy to final biopsy, up to 18 monthsPopulation: All the available targeted biopsy results are 'Not Reclassified', without any input from the other category, no comparison can be made.
Disease extent evaluated using established methods and given here by MP- erMRI classification status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline biopsy to final biopsy, up to 18 monthsPopulation: All the available targeted biopsy results are 'Not Reclassified', without any input from the other category, no comparison can be made.
Gleason Score evaluated using established methods and given here by MP- erMRI classification status.
Outcome measures
Outcome data not reported
Adverse Events
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
Serious adverse events
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=97 participants at risk
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Nervous system disorders
Syncope
|
1.0%
1/97 • From biopsy to exit visit, up to 20 months.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
|
|
Infections and infestations
Sepsis
|
1.0%
1/97 • From biopsy to exit visit, up to 20 months.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
|
|
Infections and infestations
Prostate Infection
|
1.0%
1/97 • From biopsy to exit visit, up to 20 months.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
|
Other adverse events
| Measure |
Accuracy of Multi-parametric MRI Relative to Prostate Biopsy
n=97 participants at risk
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Multiparametric MRI: an MRI of the prostate will be performed
Prostate biopsy: a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
|
|---|---|
|
Renal and urinary disorders
Hematuria
|
1.0%
1/97 • From biopsy to exit visit, up to 20 months.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.0%
1/97 • From biopsy to exit visit, up to 20 months.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
|
|
General disorders
Pain
|
1.0%
1/97 • From biopsy to exit visit, up to 20 months.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
1/97 • From biopsy to exit visit, up to 20 months.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
|
Additional Information
Neil Martin, MD
Brigham and Women's Hospital/Dana-Farber Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place