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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

Participant Flow

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
Arm/Group Description	Men eligible for screening with a s...
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

Baseline Characteristics

Arm/Group Title		MRI, PSA and US Group
Arm/Group Description		Men screened by PSA, MRI and US
Arm/Group Description		Men screened by PSA, MRI and US
Overall Number of Baseline Participants		408
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater
Description	Men with a positive MRI defined by a score of 3 or greater
Description	Men with a positive MRI defined by a score of 3 or greater
Time Frame	Through study completion, an average of 1 month

Outcome Measure Data

Analysis Population Description

All patients who had an MRI screening test


Arm/Group Title	Short MRI Arm
Arm/Group Description:	Men who had a Short MRI in study
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
Description	Men With Screen-positive Prostate MRI Defined by a Score of 4 or Great...
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

Outcome Measure Data

Analysis Population Description

All men who had a short MRI


Arm/Group Title	Short MRI Arm
Arm/Group Description:	Men who had a Short MRI in study
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
Description	Men With Screen-positive Prostate US Defined by a Score of 3 or Greate...
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

Outcome Measure Data

Analysis Population Description

All men who had a ultrasound


Arm/Group Title	Ultrasound Arm
Arm/Group Description:	Men who had a ultrasound in study
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
Description	Men With Screen-positive Prostate US Defined by a Score of 4 or Greate...
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

Outcome Measure Data

Analysis Population Description

All men who had a ultrasound


Arm/Group Title	Ultrasound Arm
Arm/Group Description:	Men who had a ultrasound in study
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
Description	Men with screen-positive PSA defined by a >/=3ng/ml
Description	Men with screen-positive PSA defined by a >/=3ng/ml
Time Frame	Through study completion, an average of 1 month

Outcome Measure Data

Analysis Population Description

Men with screen-positive PSA defined by a >/=3ng/ml


Arm/Group Title	PSA Arm
Arm/Group Description:	Men who had a PSA and one other scr...
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)

Adverse Events

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
Arm/Group Description	Men screened by PSA, MRI and US
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%)
Serious Adverse Events Serious Adverse Events
	MRI, PSA and US Group
	Affected / at Risk (%)
Total	0/408 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Würnschimmel C, Kachanov M, Wenzel M, Mandel P, Karakiewicz PI, Maurer T, Steuber T, Tilki D, Graefen M, Budäus L. Twenty-year trends in prostate cancer stage and grade migration in a large contemporary german radical prostatectomy cohort. Prostate. 2021 Sep;81(12):849-856. doi: 10.1002/pros.24181. Epub 2021 Jun 10.

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