Prostate NeoplasmPROSTAGRAMNCT03702439

Prostate Cancer Screening Trial Using Imaging

An observational study of Prostate Neoplasm, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 50 to 69 years, men onlyHealthy volunteers can take part
Conditions the study is for: Prostate Neoplasm
How many people: 411 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Oct 2018to 22 Aug 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 69 years
Men only
Healthy volunteers accepted
Adult, Older adult

Study population: Men aged 50-69 years

Who may be able to join

Men aged between 50 and 69 years inclusive at the time of study entry
Participants must be fit to undergo all procedures listed in the protocol
Estimated life expectancy of 10 years or more
An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
Participants must be willing and able to provide written informed consent

Who cannot join

Previous PSA test or prostate MRI within the prior two years of screening/consent visit
Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months
Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer
Any potential contraindication to MRI
Any potential contraindication to prostate biopsy
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
Any other medical condition precluding procedures described in the protocol

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College Healthcare NHS Trust
London

Other trials in United Kingdom

About this study

Official title: Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound

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

Bi-parametric MRI - reported by a radiologist and CAD-AI system
Multiparametric ultrasound - including shearwave elastography
A standard-of-care PSA test

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

Conditions: Prostate Neoplasm
Medical subject headings: Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
Measured: Through study completion, an average of 1 month
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
Measured: Through study completion, an average of 1 month
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater
Men With Screen-positive Prostate US Defined by a Score of 4 or Greater
Measured: Through study completion, an average of 1 month
The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml
Men with screen-positive PSA defined by a >/=3ng/ml
Measured: Through study completion, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 201822 Aug 2019

First posted11 Oct 2018
Study start10 Oct 2018
Primary completion15 May 2019
Study completion22 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 411 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03702439
Sponsor's protocol ID: 18HH4595
Acronym: PROSTAGRAM
Status last verified: Jan 2022
First submitted: 2 Oct 2018
Last updated: 27 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Eldred-Evans D, Winkler M, Klimowska-Nassar N, Burak P, Connor MJ, Fiorentino F, Day E, Price D, Gammon M, Tam H, Sokhi H, Padhani AR, Ahmed HU. Perceived patient burden and acceptability of MRI in comparison to PSA and ultrasound: results from the IP1-PROSTAGRAM study. Prostate Cancer Prostatic Dis. 2023 Sep;26(3):531-537. doi: 10.1038/s41391-023-00662-6. Epub 2023 Mar 31.
PubMed 37002379
Wurnschimmel C, Kachanov M, Wenzel M, Mandel P, Karakiewicz PI, Maurer T, Steuber T, Tilki D, Graefen M, Budaus 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.
PubMed 34110033

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms

All Prostate Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound
ClinicalTrials.gov ID: NCT03702439
Acronym / sponsor ID: PROSTAGRAM / 18HH4595
Conditions: Prostate Neoplasm
Study type: Observational
Recruitment status: Completed
Enrolment: 411 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: Imperial College Healthcare NHS Trust
Study start: 10 Oct 2018 (actual)
Primary completion: 15 May 2019 (actual)
Study completion: 22 Aug 2019 (actual)
First posted: 11 Oct 2018 (actual)
Results: Posted 27 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Bi-parametric MRI - reported by a radiologist and CAD-AI system
Multiparametric ultrasound - including shearwave elastography
A standard-of-care PSA test

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 50 to 69 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Men aged 50-69 years

Key inclusion criteria (5 listed)

Men aged between 50 and 69 years inclusive at the time of study entry
Participants must be fit to undergo all procedures listed in the protocol
Estimated life expectancy of 10 years or more
An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
Participants must be willing and able to provide written informed consent

Key exclusion criteria (7 listed)

Previous PSA test or prostate MRI within the prior two years of screening/consent visit
Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months
Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer
Any potential contraindication to MRI
Any potential contraindication to prostate biopsy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

4 secondary outcomes

The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
Time frame: Through study completion, an average of 1 month
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
Time frame: Through study completion, an average of 1 month
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater
Time frame: Through study completion, an average of 1 month
The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml
Time frame: Through study completion, an average of 1 month

Results and safety

Results posted to the registry on 27 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRI, PSA and US Group	408	408

Primary outcome: The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater

Time frame: Through study completion, an average of 1 month. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Short MRI Arm n = 406
Value	17.7 (14.3 to 21.8)

Population analysed: All patients who had an MRI screening test

4 secondary outcomes are reported in the full results.

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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI, PSA and US Group	0 of 408 (0%)	0 of 408 (0%)	0 of 408

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37002379Eldred-Evans D, Winkler M, Klimowska-Nassar N, Burak P, Connor MJ, Fiorentino F, Day E, Price D, Gammon M, Tam H, Sokhi H, Padhani AR, Ahmed HU. Perceived patient burden and acceptability of MRI in comparison to PSA and ultrasound: results from the IP1-PROSTAGRAM study. Prostate Cancer Prostatic Dis. 2023 Sep;26(3):531-537. doi: 10.1038/s41391-023-00662-6. Epub 2023 Mar 31.
Derived from this study: PubMed 34110033Wurnschimmel C, Kachanov M, Wenzel M, Mandel P, Karakiewicz PI, Maurer T, Steuber T, Tilki D, Graefen M, Budaus 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.
Individual participant dataSharing planned: Undecided

Related trials for Prostate Neoplasm

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AHMED HASHIM, Prof principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Neoplasm, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03702439, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.