Patients With High-risk Prostate Cancer Clinical Trial
Official title:
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.
| Verified date | June 2020 |
| Source | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | December 21, 2018 |
| Est. primary completion date | December 21, 2018 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario de La Princesa | Madrid | |
| Spain | Hospital Universitario de Santiago de Compostela | Santiago de Compostela | La Coruña |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
Spain,
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* Note: There are 24 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Initially a cutoff point of > 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline. | Basal | |
| Primary | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | (Initially a cutoff point of > 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline). | Post-neoadjuvant hormone therapy and prior to radiotherapy | |
| Primary | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | (Initially a cutoff point of > 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline). | Post-radiotherapy | |
| Primary | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | (Initially a cutoff point of > 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline). | 9 - 12 months post-radiotherapy in cases with positivation after basal visit | |
| Secondary | Biochemical Failure-free Survival; | Phoenix criteria (PSA Nadir +2 ng/mL) | 4 years | |
| Secondary | Overall Survival | Defined as death due to any cause | 4 years | |
| Secondary | Metastasis-free Survival | Defined as freedom from distant metastasis | 4 years | |
| Secondary | Cause Specific Survival | Defined as death caused by prostate cancer | 4 years |