PROSTAGRAM: Prostate Cancer Screening Trial Using Imaging

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03702439
• Collaborator: Imperial College Healthcare NHS Trust (Other)
• Enrollment: 411
• Location: 1
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 39.6

Study Details

Study Description

Brief Summary

Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests:

1. Bi-parametric MRI - reported by a radiologist and CAD-AI system

2. Multiparametric ultrasound - including shearwave elastography

3. A standard-of-care PSA test

A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.

Condition or Disease	Intervention/Treatment	Phase
Prostate Neoplasm

Study Design

• Study Type: Observational
• Actual Enrollment: 411 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound
• Actual Study Start Date: Oct 10, 2018
• Actual Primary Completion Date: May 15, 2019
• Actual Study Completion Date: Aug 22, 2019

Outcome Measures

Primary Outcome Measures

1. The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater [Through study completion, an average of 1 month]

   Men with a positive MRI defined by a score of 3 or greater

Secondary Outcome Measures

1. The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater [Through study completion, an average of 1 month]

   Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater

2. The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater [Through study completion, an average of 1 month]

   Men With Screen-positive Prostate US Defined by a Score of 3 or Greater

3. The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater [Through study completion, an average of 1 month]

   Men With Screen-positive Prostate US Defined by a Score of 4 or Greater

4. The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml [Through study completion, an average of 1 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 69 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Men aged between 50 and 69 years inclusive at the time of study entry

2. Participants must be fit to undergo all procedures listed in the protocol

3. Estimated life expectancy of 10 years or more

4. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process

5. Participants must be willing and able to provide written informed consent

Exclusion Criteria:

1. Previous PSA test or prostate MRI within the prior two years of screening/consent visit

2. Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months

3. Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer

4. Any potential contraindication to MRI

5. Any potential contraindication to prostate biopsy

6. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.

7. Any other medical condition precluding procedures described in the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College Healthcare NHS Trust	London		United Kingdom

Sponsors and Collaborators

• Imperial College London
• Imperial College Healthcare NHS Trust

Investigators

• Principal Investigator: AHMED HASHIM, Prof, Imperial College London

Study Documents (Full-Text)

• Study Protocol - May 1, 2019
• Statistical Analysis Plan - Oct 27, 2017

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT03702439
• Other Study ID Numbers: 18HH4595
• First Posted: Oct 11, 2018
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	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 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
Overall Participants	408
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	352 86.3%
>=65 years	56 13.7%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	408 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	94 23%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	132 32.4%
White	155 38%
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
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
Measure Participants	406
Number (95% Confidence Interval) [Percentage of participants]	17.7 4.3%

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 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
Measure Participants	406
Number (95% Confidence Interval) [Percentage of participants]	10.6 2.6%

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 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
Measure Participants	405
Number (95% Confidence Interval) [Percentage of participants]	23.7 5.8%

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 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
Measure Participants	405
Number (95% Confidence Interval) [Percentage of participants]	12.8 3.1%

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
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 screening test
Measure Participants	406
Number (95% Confidence Interval) [Percentage of participants]	9.9 2.4%

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
Arm/Group Title	MRI, PSA and US Group
Arm/Group Description	Men screened by PSA, MRI and US
All Cause Mortality
	MRI, PSA and US Group
	Affected / at Risk (%)	# Events
Total	0/408 (0%)
Serious Adverse Events
	MRI, PSA and US Group
	Affected / at Risk (%)	# Events
Total	0/408 (0%)
Other (Not Including Serious) Adverse Events
	MRI, PSA and US Group
	Affected / at Risk (%)	# Events
Total	0/408 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.