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Prostate Cancer Screening Trial Using Imaging (PROSTAGRAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702439
Recruitment Status : Completed
First Posted : October 11, 2018
Results First Posted : January 27, 2022
Last Update Posted : January 27, 2022
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Prostate Neoplasm
Enrollment 411
Recruitment Details  
Pre-assignment Details Participant enrollment (411) exceeded the planned protocol enrollment (406) due to the logistics of mpMRI at the screening site. The TMG agreed that over-recruitment could occur on a single day to maximize MRI availability
Arm/Group Title MRI, PSA and US Group
Hide Arm/Group Description Men eligible for screening with a short MRI or PSA or ultrasound
Period Title: Overall Study
Started 408
Completed 408
Not Completed 0
Arm/Group Title MRI, PSA and US Group
Hide Arm/Group Description Men screened by PSA, MRI and US
Overall Number of Baseline Participants 408
Hide Baseline Analysis Population Description
Includes men consented and eligible for all screening test
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 408 participants
<=18 years
0
   0.0%
Between 18 and 65 years
352
  86.3%
>=65 years
56
  13.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 408 participants
Female
0
   0.0%
Male
408
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 408 participants
American Indian or Alaska Native
0
   0.0%
Asian
94
  23.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
132
  32.4%
White
155
  38.0%
More than one race
9
   2.2%
Unknown or Not Reported
18
   4.4%
1.Primary Outcome
Title The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater
Hide Description Men with a positive MRI defined by a score of 3 or greater
Time Frame Through study completion, an average of 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had an MRI screening test
Arm/Group Title Short MRI Arm
Hide Arm/Group Description:
Men who had a Short MRI in study
Overall Number of Participants Analyzed 406
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
17.7
(14.3 to 21.8)
2.Secondary Outcome
Title The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
Hide Description Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
Time Frame Through study completion, an average of 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All men who had a short MRI
Arm/Group Title Short MRI Arm
Hide Arm/Group Description:
Men who had a Short MRI in study
Overall Number of Participants Analyzed 406
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
10.6
(7.9 to 14)
3.Secondary Outcome
Title The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
Hide Description Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
Time Frame Through study completion, an average of 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All men who had a ultrasound
Arm/Group Title Ultrasound Arm
Hide Arm/Group Description:
Men who had a ultrasound in study
Overall Number of Participants Analyzed 405
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
23.7
(19.8 to 28.1)
4.Secondary Outcome
Title The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater
Hide Description Men With Screen-positive Prostate US Defined by a Score of 4 or Greater
Time Frame Through study completion, an average of 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All men who had a ultrasound
Arm/Group Title Ultrasound Arm
Hide Arm/Group Description:
Men who had a ultrasound in study
Overall Number of Participants Analyzed 405
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
12.8
(9 to 16.5)
5.Secondary Outcome
Title The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml
Hide Description Men with screen-positive PSA defined by a >/=3ng/ml
Time Frame Through study completion, an average of 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Men with screen-positive PSA defined by a >/=3ng/ml
Arm/Group Title PSA Arm
Hide Arm/Group Description:
Men who had a PSA and one other screening test
Overall Number of Participants Analyzed 406
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
9.9
(7.3 to 13.2)
Time Frame Adverse events and serious adverse events were recorded and monitored continuously until the last study visit, an average of 1.5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MRI, PSA and US Group
Hide Arm/Group Description Men screened by PSA, MRI and US
All-Cause Mortality
MRI, PSA and US Group
Affected / at Risk (%)
Total   0/408 (0.00%) 
Hide Serious Adverse Events
MRI, PSA and US Group
Affected / at Risk (%)
Total   0/408 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MRI, PSA and US Group
Affected / at Risk (%)
Total   0/408 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Eldred-Evans
Organization: Imperial Prostate
Phone: 020 7594 7773
EMail: d.eldred-evans@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03702439    
Other Study ID Numbers: 18HH4595
First Submitted: October 2, 2018
First Posted: October 11, 2018
Results First Submitted: July 15, 2020
Results First Posted: January 27, 2022
Last Update Posted: January 27, 2022