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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17332543

Enrollment

490

Registered

2022-05-17

Start date

2022-02-08

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment and diagnosis of localised prostate cancer Cancer

Interventions

Current intervention as of 10/06/2022: 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 c

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 06/09/2022: 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. _____ Previous primary outcome measure: 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.	—

Measure

Time frame

Current primary outcome measure as of 06/09/2022: 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. _____ Previous primary outcome measure: 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.

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Secondary

Measure	Time frame
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. 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). 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". 4. Deaths from any cause during the first 4.5 years of follow up. 5. Overall survival at 10 years of follow up. 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. 7. Prostate cancer specific survival at 10 years of follow up.	—

Measure

Time frame

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. 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). 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". 4. Deaths from any cause during the first 4.5 years of follow up. 5. Overall survival at 10 years of follow up. 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. 7. Prostate cancer specific survival at 10 years of follow up.

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026