Clinical trial · Observational
Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy
Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
- 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)
This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen \[PSA\] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Refractory Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phlebotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- description
- Metastatic Hormone Refractory Prostate Cancer Patients
- interventionNames
- Procedure: Phlebotomy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to 36 months from time of baseline draw
Secondary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Up to 36 months after baseline draw
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> or = 18 years * Pathological diagnosis of adenocarcinoma of the prostate * First or later line of chemotherapy * Serum testosterone \< 50ng/mL * ECOG 0-2 * Serum PSA \> or = 5ng/mL * PSA progression (2 rises above a reference value) * Bone scan within 60 days of enrollment * Computed tomography (CT) scan * If measurable disease, bone scans every 6-8 months Exclusion Criteria: * Systemic radiation * Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer * Brain metastases
References
Publications (1)
- DERIVEDCoumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25. PMID 23014524