Clinical trial · Observational
Prostate Cancer Screening Trial Using Imaging
Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound
NCT03702439CI-TRIAL-00056206PROSTAGRAMcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater
- timeFrame
- Through study completion, an average of 1 month
- description
- Men with a positive MRI defined by a score of 3 or greater
Secondary outcomes (4)
- measure
- The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
- timeFrame
- Through study completion, an average of 1 month
- description
- Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
- measure
- The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
- timeFrame
- Through study completion, an average of 1 month
- description
- Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDEldred-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. PMID 37002379
- DERIVEDWurnschimmel 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. PMID 34110033