Circulating Tumour Cells as Biomarkers to Predict Prostate Cancer Metastasis for Treatment Stratification of Cancer

NCT05533515 | Completed DMC

• 2 other identifiers: 19/LO/0994140998
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to establish the value of Circulating Tumour Cell (CTC) positivity in predicting post-RP treatment failure, including BCR and new lesions detected by cancer imaging. We plan to recruit participants who will undergo Radical Prostatectomy (RP). Participants will have their blood samples taken just before surgery and 3 months after the surgery to test for CTCs. Then participants will be followed-up for cancer progression information at 3 month intervals for the first year then yearly intervals after that. Their PSA will be observed over time.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Post-RP treatment failure during the first 4.5 years of follow up from start of recruitment.

  Post-RP treatment failure is defined as a PSA ≥ 0.2mg/ml at the routine PSA test 3 months after RP (commonly called 'failure to nadir') and remaining at this level or further increase afterwards without further treatment, or imaging detected appearance of cancer lesions. Cancer lesions detected by imaging without a PSA rise might include neuroendocrine PCa and lesions detected by PSAM-PET. This combined post-RP treatment failure primary endpoint will maximally capture all the clinically significant cancer appearance events.

  4.5 years from the start of recruitment

Secondary Outcomes (6)

• BCR during the first 4.5 years of follow up

  4.5 years

• Metastasis free survival (4.5yrs)

  4.5 years

• Metastasis free survival (10yrs)

  10 years

• Deaths (4.5yrs)

  4.5 years

• 10 year survival

  10 years

Study Arms (1)

RP Treatment cohort

We will use participants who have been deemed eligible for radical prostatectomy based on the current European Urology Association classification system, and who have been scheduled for surgery to completely remove the cancer in the prostate gland.

Diagnostic Test: CTC Blood Test

Interventions

CTC Blood Test DIAGNOSTIC_TEST

We will draw blood to measure the level of Circulating Tumour Cells

RP Treatment cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In order to recruit patients meeting the eligibility criteria, it will be necessary to screen all patients in the participating centre who are diagnosed with high risk localised PCa based on the current European Urology Association classification system and who have been scheduled for surgery to completely remove the cancer in the prostate gland.

You may qualify if:

• High/High intermediate risk non-metastatic risk localised PCa based on the EAU stratification system
• Scheduled for robot-assisted RP
• Informed consent

You may not qualify if:

• With other co-occurring cancers
• Neo-adjuvant ADT
• Adjuvant ADT

Sponsors & Collaborators

• Queen Mary University of London: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College London Hospitals

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

2 x 10 ml blood samples will be collected (months 1-27) using the lavender cap EDTA tube according to our established method from each consented patient by the CRF or the clinical care team at UCLH during the pre- and post-RP PSA test blood sampling.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Greg Shaw

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: February 8, 2022
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As soon as possible after publishing the main study
• Access Criteria: Reviewed by study management group for clinical/scientific benefit.

Locations

GB (1)