Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy

June 25, 2020 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de octubre
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Hospital Universitario de Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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))

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Circulating prostatic tumor cells in the peripheral blood

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Time Frame: Basal
Initially a cutoff point of > 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline.
Basal
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Time Frame: Post-neoadjuvant hormone therapy and prior to radiotherapy
(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
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Time Frame: Post-radiotherapy
(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
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Time Frame: 9 - 12 months post-radiotherapy in cases with positivation after basal visit
(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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Failure-free Survival;
Time Frame: 4 years
Phoenix criteria (PSA Nadir +2 ng/mL)
4 years
Overall Survival
Time Frame: 4 years
Defined as death due to any cause
4 years
Metastasis-free Survival
Time Frame: 4 years
Defined as freedom from distant metastasis
4 years
Cause Specific Survival
Time Frame: 4 years
Defined as death caused by prostate cancer
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Investigators

  • Principal Investigator: Almudena Zapatero, MD, PhD, PI, Radiation Oncology Department_Hospital Universitario de La Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

December 21, 2018

Study Completion (ACTUAL)

December 21, 2018

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (ESTIMATE)

February 27, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CaPr-RTCTC-01/PI 197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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