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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests:
A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Men aged 50-69 years
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| Name | Affiliation | Role |
|---|---|---|
| AHMED HASHIM, Prof | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37002379 | Derived | 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. | |
| 34110033 |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI, PSA and US Group | Men eligible for screening with a short MRI or PSA or ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Includes men consented and eligible for all screening test
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI, PSA and US Group | Men screened by PSA, MRI and US |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All patients who had an MRI screening test | Posted | Number | 95% Confidence Interval | Percentage of participants | Through study completion, an average of 1 month |
|
|
Adverse events and serious adverse events were recorded and monitored continuously until the last study visit, an average of 1.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI, PSA and US Group | Men screened by PSA, MRI and US | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Eldred-Evans | Imperial Prostate | 020 7594 7773 | d.eldred-evans@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2019 | Jul 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2017 | Jul 15, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Men With Screen-positive Prostate US Defined by a Score of 3 or Greater |
| 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 | 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 | Through study completion, an average of 1 month |
| Derived |
| 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | 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 | All men who had a short MRI | Posted | Number | 95% Confidence Interval | Percentage of participants | Through study completion, an average of 1 month |
|
|
|
| Secondary | 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 | All men who had a ultrasound | Posted | Number | 95% Confidence Interval | Percentage of participants | Through study completion, an average of 1 month |
|
|
|
| Secondary | 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 | All men who had a ultrasound | Posted | Number | 95% Confidence Interval | Percentage of participants | Through study completion, an average of 1 month |
|
|
|
| Secondary | The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml | Men with screen-positive PSA defined by a >/=3ng/ml | Men with screen-positive PSA defined by a >/=3ng/ml | Posted | Number | 95% Confidence Interval | Percentage of participants | Through study completion, an average of 1 month |
|
|
|
| 408 |
| 0 |
| 408 |
| 0 |
| 408 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |