Can circulating tumour cells predict the spread of prostate cancer to help decide treatment of localised cancer?

Not Applicable

Conditions: Treatment and diagnosis of localised prostate cancer
Cancer

Registration Number: ISRCTN17332543

Lead Sponsor: Queen Mary University of London

Brief Summary: 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37353740/ (added 26/06/2023)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 490

Inclusion Criteria

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

Exclusion Criteria

1. With other co-occurring cancers
2. Neo-adjuvant ADT
3. Adjuvant ADT

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 06/09/2022: <br><br>Post-RP treatment failure defined as a PSA = 0.2mg/ml at the routine PSA test 3 months after RP (commonly called ‘failure to nadir’) and remaining at this level or further increase afterwards without further treatment, or imaging detected appearance of cancer lesions.<br><br>_____<br><br>Previous primary outcome measure:<br><br>Post-RP treatment failure during the first 4.5 years of follow up from start of recruitment which is defined as a PSA = 0.2mg/ml at the routine PSA test 3 months after RP (commonly called ‘failure to nadir’) and remaining at this level or further increase afterwards without further treatment, or imaging detected appearance of cancer lesions. Cancer lesions detected by imaging without a PSA rise might include neuroendocrine PCa and lesions detected by PSAM-PET. This combined post-RP treatment failure primary endpoint will maximally capture all the clinically significant cancer appearance events.

Secondary Outcome Measures

Name	Time	Method
1. BCR during the first 4.5 years of follow up: PSA = 0.2ng/ml at any time post-RP and remaining at this level or further increase afterwards without further treatment.<br>2. Metastasis (any location)-free survival during the first 4.5 years of follow up. Only 5% of subjects with distant metastasis event (based on traditional imaging technologies) within this time frame (4-6).<br>3. Metastasis (any location)-free survival at 10 years follow up. To confirm that metastatic event rates have increased among the positives, i.e. a declining rate of false positives.<br>4. Deaths from any cause during the first 4.5 years of follow up.<br>5. Overall survival at 10 years of follow up.<br>6. Prostate cancer specific deaths during the first 4.5 years of follow up. Expected to be 2% or less based on previous studies in the post RP context.<br>7. Prostate cancer specific survival at 10 years of follow up.