Digital histopathology and MRI as predictors of prostate cancer outcome in the PROMIS study

Digital histopathology metrics and baseline clinical-MRI information as predictors of prostate cancer outcome in the PROMIS study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN97047593

Enrollment

574

Registered

2024-06-14

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk stratification of prostate cancer at diagnosis Cancer

Interventions

The overarching aim of the proposed work will be to obtain clinical outcomes for men who participated in the PROMIS study and digitise all PROMIS prostate biopsy H&E slides to examine whether digital

NCT01292291) was conducted at UCL between 2012 and 2015. This study was the first to prove that MRI is a superior test for prostate cancer detection compared to standard transrectal biopsy. In total

Eligibility

Sex/Gender

Male

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Participants involved in the PROMIS trial (https://www.isrctn.com/ISRCTN16082556; NCT01292291)

Exclusion criteria

Exclusion criteria: 1. PROMIS exclusion criteria (alpha-reductase inhibitors at the time of registration or during the previous 6 months 1.1. Previous history of prostate biopsy, prostate surgery, or treatment for prostate cancer, with interventions for benign prostatic hyperplasia or bladder outflow obstruction deemed acceptable 1.2. Evidence of urinary tract infection or history of acute prostatitis within the last 3 months 1.3. Contraindications to MRI such as claustrophobia, pacemaker, estimated glomerular filtration rate =50 1.4. Any other medical condition precluding procedures described in the protocol 1.5. Previous history of hip replacement surgery, metallic hip replacement, or extensive pelvic orthopaedic metal work) 2. Lack of PROMIS consent for the use of MRI and clinical data by future researchers 3. H&E slides unavailable or damaged 4. NHS-linked data unavailable or participants opted out of clinical data collection and use

Design outcomes

Primary

Measure	Time frame
The following primary outcome variables will be measured using collected linked hospital data and generated digital prediction by the end of the study: 1. Prostate cancer-specific death 2. Death by any cause	—

Secondary

Measure	Time frame
The following secondary outcome variables will be measured using collected linked hospital data and generated digital prediction by the end of the study: 1. Time to metastasis 2. Time to disease progression 3. Prostate cancer treatment	—

Countries

England, United Kingdom

Contacts

Public ContactVasilis Stavrinides

v.stavrinides@ucl.ac.uk+44 (0)20 7679 6500

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026