Clinical trial NCT05533515: Circulating Tumour Cells as Biomarkers to Predict Prostate Cancer Metastasis for Treatment Stratification of Cancer
Official title: Circulating Tumour Cells as Biomarkers to Predict Prostate Cancer Metastasis for Treatment Stratification of Localised Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
First posted: 2022-09-09
Enrollment: 330
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Post-RP treatment failure during the first 4.5 years of follow up from start of recruitment.
timeFrame: 4.5 years from the start of recruitment
Secondary outcomes:
measure: BCR during the first 4.5 years of follow up
timeFrame: 4.5 years
measure: Metastasis free survival (4.5yrs)
timeFrame: 4.5 years
measure: Metastasis free survival (10yrs)
timeFrame: 10 years
measure: Deaths (4.5yrs)
timeFrame: 4.5 years
measure: 10 year survival
timeFrame: 10 years
measure: Prostate cancer deaths (4.5yrs)
timeFrame: 4.5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
affiliation: University College London Hospitals
name: Greg Shaw
role: PRINCIPAL_INVESTIGATOR
References: