Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma (Apa-CARDIO1)

September 23, 2020 updated by: Ospedale Andrea Tortora di Pagani

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.

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

CRPC patients without evidence of distant metastasis and in treatment with Apalutamide

Description

Inclusion Criteria:

  • CRPC patients without evidence of distant metastasis are eligible

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRPC patients
CRPC patients without evidence of distant metastasis are eligible
No Intervention on patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of arterial hypertension, by creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months
Time Frame: Almost 1 year
Evaluation of arterial hypertension, by creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months
Almost 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of biochemical response, such as 50% change in total PSA from baseline in patients receiving apalutamide
Time Frame: Almost 1 year
Assessment of biochemical response, such as 50% change in total PSA from baseline in patients receiving apalutamide
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
Time Frame: 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
Almost 1 year
Relationship between changes in blood chemistry parameters and overall survival
Time Frame: Almost 1 year
Relationship between changes in blood chemistry parameters and overall survival
Almost 1 year
Relationship between changes in blood chemistry parameters and occurrence of serious adverse events
Time Frame: Almost 1 year
Relationship between changes in blood chemistry parameters and occurrence of serious adverse events
Almost 1 year
Association between basophil count and appearance of skin rash
Time Frame: Almost 1 year
Association between basophil count and appearance of skin rash
Almost 1 year
Evaluation of drug interactions with Apalutamide
Time Frame: Almost 1 year
Evaluation of drug interactions with Apalutamide
Almost 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2020

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Castration-resistant Prostate Cancer

Clinical Trials on No Intervention on patients

3
Subscribe