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

NCT ID: NCT05533515

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2024-03-05

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.

Detailed Description

This is a single site, double-blinded, prospective, paired cohort study. Participating patients and clinicians involved in treatment or management will be blinded to the CTC results, to avoid influencing standard patient treatment, management, and progression outcomes after RP.

Patients will be recruited (months 1-24) at UCLH, where the UK largest urological surgery centre is located and performs robot-assisted RP on PCa patients referred from several regional hospitals. The clinical team at UCLH will identify eligible patients who will be approached by the clinical research fellow (CRF) employed on the research project or the clinical care team for informed consent using the consent forms specifically designed for this project for blood collection and future research. Non-metastatic disease will be based on the current standard diagnostic imaging methods including CT/MRI and PSMA-PET/bone scan. A pre-surgery PSA test will be performed routinely at UCLH.

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, and taken to the laboratory at Barts Cancer Institute, John Vane Science Centre, Charterhouse Square either by the CRF, a tissue bank acquisition officer (TBAO)(in the absence of the CRF) or the postdoc (anonymise samples transfer in the absence of CRF and TBAO) under the signed material transfer agreement (MTA), at room temperature. The samples will be transported in designated sample carrier using a taxi service. No public transport is to be used for moving samples between sites.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

CTC Blood Test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

CTC Blood Test

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University College London Hospitals

OTHER

Sponsor Role: collaborator

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Greg Shaw

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals

Locations

University College London Hospitals

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

140998

Identifier Type: OTHER

Identifier Source: secondary_id

19/LO/0994

Identifier Type: -

Identifier Source: org_study_id