N/A
N=66
Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy
Patients With High-risk Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01800058 ↗Enrolled (actual)
66
Serious AEs
10.8%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With Circulating Tumor Cells in the Peripheral Blood — 60; 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Circulating Tumor Cells in the Peripheral Blood |
12; 1 | — |
| PRIMARY Number of Participants With Circulating Tumor Cells in the Peripheral Blood |
12; 1 | — |
| PRIMARY Number of Participants With Circulating Tumor Cells in the Peripheral Blood |
12; 1 | — |
| PRIMARY Number of Participants With Circulating Tumor Cells in the Peripheral Blood |
12; 1 | — |
| SECONDARY Biochemical Failure-free Survival; |
64; 1 | — |
| SECONDARY Overall Survival |
59; 6 | — |
| SECONDARY Metastasis-free Survival |
64; 1 | — |
| SECONDARY Cause Specific Survival |
65; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01800058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.