CTC-STOP
Research type
Research Study
Full title
CTC-STOP: Utilising Circulating Tumour Cell (CTC) Counts to Optimize Systemic Therapy of Metastatic Prostate Cancer.
IRAS ID
178292
Contact name
Lorna Leonard
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2015-001361-27
Duration of Study in the UK
4 years, 3 months, 12 days
Research summary
Prostate cancer is the second most common cancer in the UK accounting for around 13% of male cancer deaths. Death from metastatic prostate cancer (where the disease spreads to other parts of the body) is generally due to resistance to hormone therapy (or androgen deprivation), with progression to a castration-resistant state usually seen after 18-24 months of hormone therapy.
Currently, two chemotherapy drugs (docetaxel and cabazitaxel) have shown survival benefit in metastatic castration-resistant prostate cancer (mCRPC). However, assessment of response to treatment can be challenging as mCRPC disease can be difficult to measure radiologically. This may result in some patients being treated for longer with drugs that are not continuing to provide clinical benefit.
In CTC-STOP we are investigating whether a blood test which detects the number of circulating tumour cells (CTC’s) could provide an earlier indicator for doctors to decide when to stop one chemotherapy treatment (docetaxel) and start another (cabazitaxel). This earlier decision-making may minimise morbidity and cost without adversely impacting patient care.
CTC-STOP is a randomised controlled phase III trial for mCRPC patients with bone metastases who have been previously treated with abiraterone and/or enzalutamide and are suitable for docetaxel treatment.
1178 patients with a CTC count of ≥ 5 cells per 7.5mL blood will be randomised to one of two groups:
•Control Group (standard of care): Standard docetaxel treatment until disease progression determined by the clinician or completion of 10 cycles.
•Intervention Group (CTC-guided treatment group): Standard docetaxel treatment until disease progression defined by CTC count criteria and/or progression determined by the clinician or completion of 10 cycles.Patients who discontinue docetaxel treatment will be switched to second-line chemotherapy with cabazitaxel (if indicated) until progression or completion of 10 cycles.
The primary endpoint is overall survival. Secondary endpoints include response and progression-related events, pain, quality of life and health economic measures.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/1502
Date of REC Opinion
21 Sep 2016
REC opinion
Favourable Opinion