Clinical trial · Observational
Exploiting Risk-Based Risk Stratification in Early Prostate Cancer to Discriminate Progressors From Non-Progressors
NCT04340245CI-TRIAL-00074356RECONCILEactive not recruitingClinicalTrials.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)
This study seeks to analyse MRI images and biological samples from 60 men diagnosed as having intermediate risk prostate cancer at baseline and one year afterwards to compare the molecular, genetic and transcriptomic differences between cancers that progress and cancers which do not.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NA (Observational) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion
- timeFrame
- 12 months
- description
- Proportion of concordant pairs molecular progressor- radiological progressor.
Secondary outcomes (20)
- measure
- Progression time
- timeFrame
- 12 months
- description
- Time to radiological progression
- measure
- Lesion imaging characteristics
- timeFrame
- 12 months
- description
- Quantitative and qualitative imaging characteristics of MRI lesions
- measure
- Prostate imaging changes - quantitative
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male aged 18 years or above. * Diagnosed with prostate cancer within 4 months of entry. * Likert or PIRADS score greater than or equal to 4. * PSA less than or equal to 15 ng.ml-1 in the last 6 months. * mpMRI concordant with histology. * Overall Gleason score 7 (3+4). * Maximum cancer core length less than or equal to 10mm. * Patients on active surveillance Exclusion Criteria: * Any contraindication to MRI scans (e.g. metal implants, unmanageable claustrophobia) * Presence of a pacemaker * Presence of a hip replacement * Any hormonal treatment or inhibitors of 5 alpha-reductase in the previous 6 months * Any previous TURP or other prostate surgery. * Previous treatment for prostate cancer. * Patients who have previously had sepsis due to a prostate biopsy * Patients receiving concomitant treatment for their cancer * Inability to provide full informed consent (e.g. due to dementia)
References
Publications (1)
- DERIVEDMarsden T, Attard G, Punwani S, Giganti F, Freeman A, Haider A, Wingate A, Williams N, Syer T, Pashayan N, Moore CM, Emberton M, Orczyk C. The RECONCILE study protocol: Exploiting image-based risk stratification in early prostate cancer to discriminate progressors from non-progressors (RECONCILE). PLoS One. 2024 Oct 17;19(10):e0295994. doi: 10.1371/journal.pone.0295994. eCollection 2024. PMID 39418289