Castration-resistant Prostate CancerApa-CARDIO1NCT04567875
Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma
An observational study of Castration-resistant Prostate Cancer, run by Ospedale Andrea Tortora di Pagani at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- How many people
- 54 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Jul 2020to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Child, Adult, Older adult
Study population: CRPC patients without evidence of distant metastasis and in treatment with Apalutamide
Who may be able to join
- CRPC patients without evidence of distant metastasis are eligible
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Oncology Unit, Hospital Andrea Tortora
Pagani, Salerno, 84016
Data Manager Oncology Unit, +390819213683, trialclinici.oncopagani@gmail.com
Data Manager Oncology Unit, +390819213658, trialclinici.oncopagani@gmail.com
- Recruiting
Oncology Unit, Ospedale Andrea Tortora
Pagani, Salerno, 84016
Data Manager Oncology Unit, +360819213683, trialclinici.oncopagani@gmail.com
Data Manager Oncology Unit, +360819213658, trialclinici.oncopagani@gmail.com
About this study
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.
Read the 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.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- No Intervention on patients
- Keywords
- Apalutamide, Oncological patients, Cancer, CRPC
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention on patientsOther
No Intervention on patients
| Study group | Role | What they receive |
|---|---|---|
| CRPC patients | CRPC patients without evidence of distant metastasis are eligible Receives: Other: No Intervention on patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of arterial hypertension, by creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months
Evaluation of arterial hypertension, by creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months
Measured: Almost 1 year
Secondary outcomes (6)
Assessment of biochemical response, such as 50% change in total PSA from baseline in patients receiving apalutamide
Assessment of biochemical response, such as 50% change in total PSA from baseline in patients receiving apalutamide
Measured: 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 time to onset of metastases, assessed by PET PSMA or bone scan or CT scan
Measured: Almost 1 year
Relationship between changes in blood chemistry parameters and overall survival
Relationship between changes in blood chemistry parameters and overall survival
Measured: Almost 1 year
Relationship between changes in blood chemistry parameters and occurrence of serious adverse events
Relationship between changes in blood chemistry parameters and occurrence of serious adverse events
Measured: Almost 1 year
Association between basophil count and appearance of skin rash
Association between basophil count and appearance of skin rash
Measured: Almost 1 year
Evaluation of drug interactions with Apalutamide
Evaluation of drug interactions with Apalutamide
Measured: Almost 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start16 Jul 2020
- Primary completionMar 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Andrea Tortora di Pagani
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567875
- Sponsor's protocol ID
- APA-CARDIO_PAG_01
- Acronym
- Apa-CARDIO1
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma
- ClinicalTrials.gov ID
- NCT04567875
- Acronym / sponsor ID
- Apa-CARDIO1 / APA-CARDIO_PAG_01
- Conditions
- Castration-resistant Prostate Cancer
- Keywords
- Apalutamide, Oncological patients, Cancer, CRPC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ospedale Andrea Tortora di PaganiResearch network
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRPC patients | – | Other: No Intervention on patientsCRPC patients without evidence of distant metastasis are eligible |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- CRPC patients without evidence of distant metastasis and in treatment with Apalutamide
Key inclusion criteria (1 listed)
- CRPC patients without evidence of distant metastasis are eligible
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention on patientsNo Intervention on patients | Other | CRPC patients |
Primary outcome
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
6 secondary outcomes
Assessment of biochemical response, such as 50% change in total PSA from baseline in patients receiving apalutamide
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
Time frame: 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 occurrence of serious adverse events
Time frame: Almost 1 year
Association between basophil count and appearance of skin rash
Time frame: Almost 1 year
Evaluation of drug interactions with Apalutamide
Time frame: Almost 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Castration-resistant Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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RecruitingObservational study
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Castration-resistant Prostate Cancer, run by Ospedale Andrea Tortora di Pagani at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.