Clinical trial · Observational
Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy
Prognostic Value of the Levels of Circulating Tumor Cells (CTCs) in Peripheral Blood in Patients With Prostate Cancer at High Risk (Clinical Stages IIB-III) Treated Radically With Radiotherapy and Hormone Therapy.
NCT01800058CI-TRIAL-00045696completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 detection and quantification of Circulating tumor cells CTCs in peripheral blood of patients with prostate adenocarcinoma may be useful at least for: Getting a correct stratification of patients with high-risk prostate cancer (PCa). Set the prognosis at baseline. Evaluate the response to different treatments (predictive value and monitoring). Establish individualized therapies.
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 |
|---|---|---|---|
| Patients With High-risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Circulating prostatic tumor cells in the peripheral blood
- description
- Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL): 1. prior to any treatment; 2. following AD and prior to RT; and 3. following the end of RT (1-3 months afterwards). 4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination The quantification of CTC in blood samples will be done with the CellSearch® system.
Primary outcomes (4)
- measure
- Number of Participants With Circulating Tumor Cells in the Peripheral Blood
- timeFrame
- Basal
- description
- Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline.
- measure
- Number of Participants With Circulating Tumor Cells in the Peripheral Blood
- timeFrame
- Post-neoadjuvant hormone therapy and prior to radiotherapy
- description
- (Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged \> 18 with capacity to give informed consent. * Patients with histologically confirmed prostate cancer. * Patients with a high risk factor: PSA\> 20 ng / ml, Gleason 8-10 and / or stage T3a-b, N0M0 (NCCN 2011, stage IIB-III AJCC classification 2010). Staging by: Histology-Gleason score-, PSA, TR, ECO TR, CT, MRI. * Patients who accept radical treatment with radiotherapy. * Patients who give written informed consent to participate in the study Exclusion Criteria: * Any patient diagnosed with prostate cancer, which does not meet the prerequisites. * Any patients with another malignancy diagnosed in the past 5 years (except basal cell or squamous cell carcinoma of skin). * Any patient who has prostate biopsy performed 7 days prior to study entry. * Patients who have received prior treatment with hormonal therapy, chemotherapy or radiotherapy. * Patients with PSA\> 100 ng / ml. * Any situation or condition of the patient which in the opinion of the investigator, advised against participation in the study.
References
Publications (24)
- BACKGROUNDDamber JE, Aus G. Prostate cancer. Lancet. 2008 May 17;371(9625):1710-21. doi: 10.1016/S0140-6736(08)60729-1. PMID 18486743
- BACKGROUNDZelefsky MJ, Yamada Y, Fuks Z, Zhang Z, Hunt M, Cahlon O, Park J, Shippy A. Long-term results of conformal radiotherapy for prostate cancer: impact of dose escalation on biochemical tumor control and distant metastases-free survival outcomes. Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):1028-33. doi: 10.1016/j.ijrobp.2007.11.066. Epub 2008 Feb 14. PMID 18280056
- BACKGROUNDKuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31. PMID 17765406
- BACKGROUNDRoach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. doi: 10.1200/JCO.2007.13.9881. Epub 2008 Jan 2. PMID 18172188
- BACKGROUNDHorwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. doi: 10.1200/JCO.2007.14.9021. Epub 2008 Apr 14. PMID 18413638
- BACKGROUNDShaffer DR, Leversha MA, Danila DC, Lin O, Gonzalez-Espinoza R, Gu B, Anand A, Smith K, Maslak P, Doyle GV, Terstappen LW, Lilja H, Heller G, Fleisher M, Scher HI. Circulating tumor cell analysis in patients with progressive castration-resistant prostate cancer. Clin Cancer Res. 2007 Apr 1;13(7):2023-9. doi: 10.1158/1078-0432.CCR-06-2701.