The RECONCILE study protocol: Exploiting image-based risk stratification in early prostate cancer to discriminate...

Area of Science:

• Oncology
• Radiology
• Genomics

Background:

• The RECONCILE study (NCT04340245) focuses on localized, newly diagnosed Gleason 3+4 prostate tumors.
• It aims to identify molecular and radiomic markers linked to clinical and radiological progression.

Purpose of the Study:

• To identify molecular and radiomic markers associated with clinical and radiological progression in intermediate-risk prostate cancer.
• To correlate molecular markers with standard MRI-targeted histology and oncological outcomes.

Main Methods:

• A prospective, longitudinal, observational cohort study of 60 treatment-naïve participants with Gleason 3+4 prostate cancer.
• Collection of blood, urine, and prostate tissue for next-generation sequencing at baseline and one year.
• Radiomic analysis of standard-of-care MRI data to assess radiological progression (PRECISE score 4 or 5).

Main Results:

• Recruitment commenced in July 2020, enrolling 62 participants.
• Tissue analysis is underway, with 37 participants having donated samples to date.

Conclusions:

• A prospective study has been established to evaluate the molecular landscape of intermediate-risk, MRI-visible prostate tumors.
• The study is ongoing, with recruitment continuing to gather comprehensive data.