C-ProMeta-1

Full Title: Circulating tumour cells as biomarkers to predict prostate cancer metastasis for treatment stratification of localised cancer

Study acronym: C-ProMeta-1 

Sponsor: Queen Mary University of London

Funder: Prostate Cancer UK

Chief Investigator: Prof Yong-Jie Lu, Professor of Molecular Oncology, Queen Mary University of London

Contact: y.j.lu@qmul.ac.uk (Yong-Jie Lu)

Registration: https://clinicaltrials.gov/study/NCT05533515

Background:

Prostate cancer is the most common cancer in men worldwide. Many tumours grow slowly, meaning that immediate treatment—often associated with side effects—may not always be necessary. In some cases, however, cancer behaves more aggressively even when it appears confined to the prostate, a stage known as localised prostate cancer.

Localised prostate cancer can often be treated with surgery or radiotherapy. Once cancer spreads beyond the prostate, these treatments alone are unlikely to be curative. Clinicians use tools like biopsies, PSA blood tests, and scans to determine whether cancer is still contained, but very small areas of spread may go undetected.

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Purpose of the Study:

Radical prostatectomy, which involves surgical removal of the prostate, is a common treatment for prostate cancer. In some patients, cancer may return after surgery. One explanation is that cancer cells may have entered the bloodstream before the prostate is removed, forming tiny clusters known as micrometastases, which current diagnostic methods cannot detect.

This study aims to develop a more accurate method to identify which patients are suitable for surgery alone and which may benefit from additional systemic treatments, including hormone therapy, radiotherapy, or chemotherapy.

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Detecting Circulating Tumour Cells:

Cancer can spread through circulating tumour cells (CTCs), which travel in the bloodstream. Researchers at Queen Mary University of London have developed a technique to detect these cells using only a blood sample. Testing for CTCs in patients with localised prostate cancer may reveal early signs of spread that scans or biopsies cannot detect. This approach can help clinicians select the most appropriate treatment plan.

C-ProMeta-1 is designed to evaluate how accurate this CTC detection method is in patients undergoing prostate removal surgery.

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Who Can Take Part?:

Participants may be eligible if they have unfavourable intermediate, high, or very high-risk localised prostate cancer and are scheduled for a radical prostatectomy. All participants receive written information about the study and give informed consent to a qualified doctor.

Risk categories are based on the National Comprehensive Cancer Network (NCCN) guidelines.

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What Participation Involves:

Participants will provide an additional blood sample at two time points:

• Before surgery

• Three months after surgery

Each sample requires 20 ml of blood (approximately four teaspoons). Samples are collected during routine clinic visits, so no extra appointments are needed.

At the start of the study, information about each participant’s diagnosis and treatment will be collected. Participants will be followed for at least 10 years to determine whether CTCs can predict cancer recurrence.

The study plans to recruit approximately 300 participants over a two-year period.

Recruitment Status:

- Status: No longer recruiting

- Date of final enrolment: 01/01/2024

Expected Outcomes:

Clinical information from all participants will be combined with blood test results to evaluate how well CTC detection predicts cancer recurrence after surgery. Analysing these data may help identify patterns of disease progression and treatment response, supporting the development of more personalised treatment strategies for prostate cancer patients.

Study Completion Date:

• 01/01/2034