Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma
Apa-CARDIO1
1 other identifier
observational
54
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2020
CompletedFirst Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedSeptember 29, 2020
September 1, 2020
1.6 years
September 17, 2020
September 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Almost 1 year
Secondary Outcomes (6)
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
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
Almost 1 year
Association between basophil count and appearance of skin rash
Almost 1 year
- +1 more secondary outcomes
Study Arms (1)
CRPC patients
CRPC patients without evidence of distant metastasis are eligible
Interventions
Eligibility Criteria
CRPC patients without evidence of distant metastasis and in treatment with Apalutamide
You may qualify if:
- CRPC patients without evidence of distant metastasis are eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Oncology Unit, Hospital Andrea Tortora
Pagani, Salerno, 84016, Italy
Oncology Unit, Ospedale Andrea Tortora
Pagani, Salerno, 84016, Italy
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
September 29, 2020
Study Start
July 16, 2020
Primary Completion
March 1, 2022
Study Completion
September 1, 2022
Last Updated
September 29, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share