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PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide. (PROSENZA)

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ClinicalTrials.gov Identifier: NCT02922218
Recruitment Status : Unknown
Verified January 2020 by Centro Nacional de Investigaciones Oncologicas CARLOS III.
Recruitment status was:  Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Information provided by (Responsible Party):
Centro Nacional de Investigaciones Oncologicas CARLOS III

Brief Summary:
PROSENZA is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with enzalutamide

Condition or disease
Advanced Prostate Cancer Castration Resistant Enzalutamide

Detailed Description:
This study is a prospective biomarker study of patients with mCRPC undergoing treatment with enzalutamide as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

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Study Type : Observational
Estimated Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide.
Study Start Date : June 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
Enzalutamide
Enzalutamide 160 mg/day c/24h



Primary Outcome Measures :
  1. To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients [ Time Frame: Initially 48 months, currently 60 months ]

Secondary Outcome Measures :
  1. To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide. [ Time Frame: Initially 48 months, currently 60 months ]
  2. To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment [ Time Frame: Initially 48 months, currently 60 months ]
  3. To explore the correlation between AR-V7 expression and AR amplification with other biomarkers as testosterone serum levels, PTEN loss or TMPRSS-ERG fusions in mCRPC patients treated with Enzalutamide [ Time Frame: Initially 48 months, currently 60 months ]
  4. To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients [ Time Frame: Initially 48 months, currently 60 months ]

Other Outcome Measures:
  1. To validate the independent prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients [ Time Frame: Initially 48 months, currently 60 months ]
  2. To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients [ Time Frame: Initially 48 months, currently 60 months ]

Biospecimen Retention:   Samples With DNA
Whole blood and archival FFPE


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
metastatic Castration-Resitant Prostate Cancer patients
Criteria

Inclusion Criteria:

  1. Male age ≥ 18 years
  2. Histologically confirmed adenocarcinoma of the prostate
  3. ECOG Performance Status ≤ 2
  4. Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/mL (< 2.0 nM).
  5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
  6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
  7. Patients who are candidates for standard of care treatment with enzalutamide 160 mg every 24 hours.
  8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
  9. Acceptable hematological, hepatic and renal functions.

Exclusion Criteria:

  1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
  2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data

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): NCT02922218


Locations
Show Show 26 study locations
Sponsors and Collaborators
Centro Nacional de Investigaciones Oncologicas CARLOS III
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
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Study Chair: David Olmos, MD CNIO-Centro Nacionald e Investigaciones Oncológicas
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Responsible Party: Centro Nacional de Investigaciones Oncologicas CARLOS III
ClinicalTrials.gov Identifier: NCT02922218    
Other Study ID Numbers: IBIMA-CNIO-CP-01-2016
CNI-ENZ-2016-01 ( Other Identifier: CNIO )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centro Nacional de Investigaciones Oncologicas CARLOS III:
metastatic Castration Resistant Prostate Cancer
Enzalutamide
Biomarkers
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases