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Trial record 2 of 3 for:    18413638 [PUBMED-IDS]

Prognostic Value of the Levels of CTCs in Peripheral Blood in Patients With Prostate Cancer at High Risk (Clinical Stages IIB-III) Treated Radically With Radiotherapy and Hormone Therapy.

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ClinicalTrials.gov Identifier: NCT01800058
Recruitment Status : Unknown
Verified February 2013 by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa.
Recruitment status was:  Not yet recruiting
First Posted : February 27, 2013
Last Update Posted : February 27, 2013
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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.


Condition or disease
Patients With High-risk Prostate Cancer

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 3 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). 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
Estimated Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : March 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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).

The quantification of CTC in blood samples will be done with the CellSearch® system.




Primary Outcome Measures :
  1. expression of circulating tumor cells in the peripheral blood in the peripheral blood of patients with high-risk prostate cancer (NCCN 2011) [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]
    (Initially a cutoff point of > 3 or more circulating cells per 7.5 ml of blood will be taken as the reference baseline).


Secondary Outcome Measures :
  1. Radiation dose [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]
  2. Duration and type of hormone therapy [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]
  3. Gleason sum; [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]
  4. Pretreatment PSA; [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]
  5. Clinical T stage [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]
  6. Biochemical failure-free survival; [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]
  7. Overall Survival defined as death due to any cause; [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]
  8. Metastasis-free survival [ Time Frame: Following the end of radiotherapy (1-3 months afterwards). ]

Biospecimen Retention:   Samples Without DNA

Prospective analysis of biological material from samples of peripheral blood (PB) of 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))

The sampling of peripheral blood (PB) for detection of CTCs in three treatment periods:

  • Before starting any treatment-DA initially neoadjuvant
  • Prior to the start of RT (DA after neoadjuvant)
  • At the end of RT (1-3 months) The analysis-quantification of CTCs obtained in these phases, will correlate with treatment outcomes in terms of biochemical failure (BF) according to the criteria of Phoenix 2006 and overall survival and metastasis-free to identify potential prognostic value. Likewise determinations are compared before and after CTCs DA and RT to evaluate the effect of such treatments on modular quantifying CTCs (predictive value).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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))
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800058


Contacts
Contact: Almudena Zapatero, MD, PhD; PI +34915202315 almudena.zapatero@salud.madrid.org

Locations
Spain
Hospital Universitario de Santiago de Compostela Not yet recruiting
Santiago de Compostela, La Coruña, Spain, 15706
Contact: Almudena Zapatero, MD    +34915202315      
Principal Investigator: Antonio Gómez Caamaño, MD         
Sub-Investigator: Luis León, MD         
Hospital Universitario de La Princesa Not yet recruiting
Madrid, Spain, 28006
Contact: Almudena Zapatero, MD PhD    +34915202315    azapatero.hlpr@salud.madrid.org   
Principal Investigator: Almudena Zapatero, MD PhD         
Sub-Investigator: Carlos Olivier, MD         
Sub-Investigator: Carmen Martín de Vidales, MD         
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Contact: Almudena Zapatero, MD    +34915202315      
Principal Investigator: María Ángeles Cabeza, MD         
Sub-Investigator: Alfredo Rodríguez Antolín, MD         
Sponsors and Collaborators
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 of Results:

Other Publications:
Bolla M, Collette L, Van Tienhoven G, et al. Ten-year results of long-term adjuvant androgen deprivation with goserelin in patients with locally advanced prostate cancer treated with radiotherapy: A phase III EORTC study. Int J Radiat Oncol Biol Phys 2008;72:S30-S31.
L. Resel Folkersma, C. Olivier Gómez, L. San José Manso, et al. Cuantificación Inmunomagnética De Células Tumorales Circulantes En Pacientes Con Cáncer De Próstata: Correlación Clínica Y Patológica. Arch. Esp. Urol. 2010; 63 (1): 23-31

Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT01800058     History of Changes
Other Study ID Numbers: CaPr-RTCTC-01/PI 197
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs