Clinical trial NCT01800058: Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With High-risk Prostate Cancer
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with prostate cancer at high risk (NCCN 2011), AJCC stage IIB-III, treated with 3D-CRT, IMRT dose escalation (with androgen deprivation (DA))

Brief 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.

Detailed description: Prospective analysis of biologic samples from peripheral blood of 65 patients with localized high-risk PCa (NCCN 2011) treated with RTC-3D-IMRT combined with AD.

Following the sign of the informed consent of the patient, the blood samples will be analyzed for CTCs using an immunomagnetic method based on the CellSearch system (Veridex), in 4 periods of time:

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

Comparison between the expression of CTCs in peripheral blood before and following AD and RT will be performed. The quantification of the CTCs obtained in these phases of treatment will be correlated with the treatment results in terms of biochemical failure according to Phoenix definition, distant metastasis rate and overall survival to identify a significant prognostic relationship and to determine the potential effect of the treatment in the number of CTCs Our working group will include 65 patients because the amount is based on routine clinical activity can be safely enrolled in the project development time by the participating centers.

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.

Primary outcomes:
measure: Number of Participants With Circulating Tumor Cells in the Peripheral Blood
timeFrame: Basal
measure: Number of Participants With Circulating Tumor Cells in the Peripheral Blood
timeFrame: Post-neoadjuvant hormone therapy and prior to radiotherapy
measure: Number of Participants With Circulating Tumor Cells in the Peripheral Blood
timeFrame: Post-radiotherapy
measure: Number of Participants With Circulating Tumor Cells in the Peripheral Blood
timeFrame: 9 - 12 months post-radiotherapy in cases with positivation after basal visit
Secondary outcomes:
measure: Biochemical Failure-free Survival;
timeFrame: 4 years
measure: Overall Survival
timeFrame: 4 years
measure: Metastasis-free Survival
timeFrame: 4 years
measure: Cause Specific Survival
timeFrame: 4 years
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
state: La Coruña
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Radiation Oncology Department_Hospital Universitario de La Princesa
name: Almudena Zapatero, MD, PhD, PI
role: PRINCIPAL_INVESTIGATOR
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