Clinical trial · Observational
Circulating Tumour Cells as Biomarkers to Predict Prostate Cancer Metastasis for Treatment Stratification of Cancer
Circulating Tumour Cells as Biomarkers to Predict Prostate Cancer Metastasis for Treatment Stratification of Localised Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTC Blood Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- RP Treatment cohort
- description
- We will use participants who have been deemed eligible for radical prostatectomy 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.
- interventionNames
- Diagnostic Test: CTC Blood Test
Primary outcomes (1)
- measure
- Post-RP treatment failure during the first 4.5 years of follow up from start of recruitment.
- timeFrame
- 4.5 years from the start of recruitment
- description
- Post-RP treatment failure 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 outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available