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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02922218 |
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Date of registration:
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29/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.
PROSENZA |
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Scientific title:
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Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide. |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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187 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02922218 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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David Olmos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CNIO-Centro Nacionald e Investigaciones Oncológicas |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Advanced Prostate Cancer
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Castration Resistant
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Enzalutamide
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment
[Time Frame: Initially 48 months, currently 60 months]
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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]
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Secondary ID(s)
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CNI-ENZ-2016-01
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IBIMA-CNIO-CP-01-2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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