Exploiting Risk-Based Risk Stratification in Early Prostate Cancer to Discriminate Progressors From Non-Progressors

NCT04340245 | Active Not Recruiting DMC

• 1 other identifier: 127742
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

MRI; MRI progression; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion

  Proportion of concordant pairs molecular progressor- radiological progressor.

  12 months

Secondary Outcomes (20)

• Progression time

  12 months

• Lesion imaging characteristics

  12 months

• Prostate imaging changes - quantitative

  12 months

• Prostate imaging changes - qualitative

  12 months

• Imaging characteristics comparison

  12 months

Interventions

NA (Observational) OTHER

No interventions will be carried out. Comparisons will be made between patients whose cancer has progressed over the course of one year and patients whose cancer hasn't.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be men with prostate cancer
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men over the age of 18 with prostate cancer (Gleason 3+4) who are on active surveillance.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College Hospital

London, United Kingdom

Location

Related Publications (1)

• Marsden 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, semen, prostate tissue from biopsy.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sodium

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: April 9, 2020
• Study Start: July 1, 2020
• Primary Completion: March 30, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)