Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma
NCT ID: NCT04567875
Last Updated: 2020-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
54 participants
OBSERVATIONAL
2020-07-16
2022-09-30
Brief Summary
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In case of a favorable opinion from the patient, the CRF will be filled in. Patients with CRPC M0 treated with Apalutamide, belonging to the Oncology Unit of the Pagani Hospital "Andrea Tortora" and of the other Oncology Units of the ASL of Salerno (Hospital of Vallo della Lucania) will be studied with the possibility of enrollment also from other Centers outside the Salerno ASL.
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Detailed Description
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Primary objective:
-Evaluation of arterial hypertension, by periodic measurement of blood pressure every week (1-3 times), creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months, with stratification of patients under treatment according to the degree of AI found.
Secondary objectives:
* Evaluation of cardiological toxicity, through the execution of ECG, periodic echocardiography for the evaluation of the ejection fraction of the left ventricle, cardiac markers (troponin, CK-MB, pro-BNP)
* Assessment of the biochemical response, such as a 50% reduction in total PSA compared to baseline in patients receiving apalutamide;
* Evaluation of the change in blood chemistry parameters in the patient being treated with Apalutamide;
* Relationship between changes in blood chemistry parameters and time to the onset of metastases, assessed by PET PSMA or bone scan or CT scan;
* Relationship between changes in blood chemistry parameters and overall survival;
* Relationship between changes in blood chemistry parameters and occurrence of serious adverse events;
* Association between basophil counts and appearance of skin rash;
* Evaluation of drug interactions with Apalutamide.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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CRPC patients
CRPC patients without evidence of distant metastasis are eligible
No Intervention on patients
No Intervention on patients
Interventions
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No Intervention on patients
No Intervention on patients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
MALE
No
Sponsors
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Ospedale Andrea Tortora di Pagani
NETWORK
Responsible Party
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Locations
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Oncology Unit, Hospital Andrea Tortora
Pagani, Salerno, Italy
Oncology Unit, Ospedale Andrea Tortora
Pagani, Salerno, Italy
Countries
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Facility Contacts
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Other Identifiers
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APA-CARDIO_PAG_01
Identifier Type: -
Identifier Source: org_study_id
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