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Trial Title:
Circulating Tumour Cells as Biomarkers to Predict Prostate Cancer Metastasis for Treatment Stratification of Cancer
NCT ID:
NCT05533515
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Neoplastic Cells, Circulating
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CTC Blood Test
Description:
We will draw blood to measure the level of Circulating Tumour Cells
Arm group label:
RP Treatment cohort
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University College London Hospitals
Address:
City:
London
Country:
United Kingdom
Start date:
February 8, 2022
Completion date:
January 1, 2032
Lead sponsor:
Agency:
Queen Mary University of London
Agency class:
Other
Collaborator:
Agency:
University College London Hospitals
Agency class:
Other
Source:
Queen Mary University of London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05533515
