Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma

• Conditions: Castration-resistant Prostate Cancer
• Interventions: Other: No Intervention on patients

• Registration Number: NCT04567875
• Lead Sponsor: Ospedale Andrea Tortora di Pagani

Brief Summary

This is a prospective observational study on a cohort of patients with castration-resistant prostate cancer M0, treated with Apalutamide, at the Oncology Unit of the "Andrea Tortora" Hospital of Pagani. Data will be collected on the patient's clinical history and the treatments carried out until the start of therapy with Apalutamide. At that time the study will be described to the patient and informed consent will be given.

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.

Detailed Description

The CRPC M0 patient will be identified by PET PSMA, or CT scan and Bone Scanning at the clinician's discretion based on the physical examination performed at the patient's first access. The reassessment of the disease status is to be repeated by PET-PSMA, CT scan or bone scan (in relation to the examination carried out at baseline) in a period of time ranging from 6 to 12 months after the first access, based on the assessment of the health status of the patient and tolerability to treatment after careful evaluation by the clinician. The blood chemistry routine including CBC with white blood cell formula will be repeated every 30 days. The patient will be provided with a blood pressure monitoring diary every 30 days. The measurement of cardiac markers will be performed every 60 days. The evaluation of the cardiological function will be carried out by means of ECG, echocardiography with determination of the LVEF, 24-hour Holter blood pressure every 6 months. Bone mineral density assessment will be monitored by MOC-DEXA every 6 months. Possible drug interactions with Apalutamide will be identified.

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.

Study Timeline

• Study Start: 2020-07-16
• Status Verified: 2020-09
• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29
• Primary Completion: 2022-03
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

• CRPC patients without evidence of distant metastasis are eligible

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRPC patients	No Intervention on patients	CRPC patients without evidence of distant metastasis are eligible

Primary Outcome Measures

Name	Time	Method
Evaluation of arterial hypertension, by creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months	Almost 1 year	Evaluation of arterial hypertension, by creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months

Secondary Outcome Measures

Name	Time	Method
Assessment of biochemical response, such as 50% change in total PSA from baseline in patients receiving apalutamide	Almost 1 year	Assessment of biochemical response, such as 50% change in total PSA from baseline in patients receiving apalutamide
Relationship between changes in blood chemistry parameters and time to onset of metastases, assessed by PET PSMA or bone scan or CT scan	Almost 1 year	Relationship between changes in blood chemistry parameters and time to onset of metastases, assessed by PET PSMA or bone scan or CT scan
Relationship between changes in blood chemistry parameters and overall survival	Almost 1 year	Relationship between changes in blood chemistry parameters and overall survival
Relationship between changes in blood chemistry parameters and occurrence of serious adverse events	Almost 1 year	Relationship between changes in blood chemistry parameters and occurrence of serious adverse events
Evaluation of drug interactions with Apalutamide	Almost 1 year	Evaluation of drug interactions with Apalutamide
Association between basophil count and appearance of skin rash	Almost 1 year	Association between basophil count and appearance of skin rash

Trial Locations

Locations (2)

Oncology Unit, Hospital Andrea Tortora; 🇮🇹 Pagani, Salerno, Italy

Oncology Unit, Ospedale Andrea Tortora; 🇮🇹 Pagani, Salerno, Italy