None listed
Conditions
Brief summary
Purpose: The primary purpose of this study is to establish the electronic Prostate Cancer Australian database (ePAD), a national, multi-site, prospective cohort study. The data collected will be used to evaluate real-world patterns of care for Australians with hormone-sensitive prostate cancer (HSPC) and castration-resistant prostate cancer (CRPC), and to identify factors that may influence treatment decisions and outcomes. Who is it for? Patients will be 'recruited' at participating sites; these sites will submit an ethics application to enable them to collect patient data from routine clinical practice. This is a non-interventional study and purely data collection at the approved site/hospital. Study details: Data will be collected at baseline and updated at subsequent clinic visits. Information captured includes patient demographics, clinical and pathological characteristics at diagnosis, local treatments, use of androgen deprivation therapy, diagnosis of CRPC, systemic therapy use and effectiveness, survival outcomes, and the rationale for treatment selection or change. Factors such as comorbidities, disease burden, prior treatment responses, drug-specific considerations, and patient preference will also be recorded. Follow-up data will continue to be collected beyond the initial enrolment period to provide long-term insights into treatment patterns and outcomes. It is anticipated that findings from this study will improve understanding of how prostate cancer is managed in real-world clinical practice across oncology, urology, and radiation oncology. The results may also contribute to determining the optimal sequencing of systemic therapies and help guide more personalised treatment decisions for men with prostate cancer.
Interventions
There is currently limited evidence informing the “optimal sequence” of and choice of treatments in HSPC and CRPC. In the absence of validated biomarkers, clinicians currently use clinicopathological factors to assist them in sequencing treatments in individual patients. These factors may include the clinical status of the patient (asymptomatic or symptomatic), their co-morbidities, the burden of disease and rate of progression, the presence of visceral or bony metastases, prior treatments and r
There is currently limited evidence informing the “optimal sequence” of and choice of treatments in HSPC and CRPC. In the absence of validated biomarkers, clinicians currently use clinicopathological factors to assist them in sequencing treatments in individual patients. These factors may include the clinical status of the patient (asymptomatic or symptomatic), their co-morbidities, the burden of disease and rate of progression, the presence of visceral or bony metastases, prior treatments and responses to each treatment, as well as drug-specific factors such as the mechanism of action, tolerability and side effect profile. Patient preference, the availability of reimbursed medications or suitable clinical trials may also influence treatment selection. The increasingly difficult financial environment for medical research has made it more difficult to conduct large studies aimed at determining the optimal sequence. Subsequently, the use of large, well-annotated and appropriately designed databases that prospectively record real-world treatment patterns has become increasingly important. The electronic Prostate Cancer Australian database (ePAD) is a multi-site, national prospective cohort study that collects data regarding baseline patient characteristics, details regarding initial diagnosis including pathological characteristics, local treatment and the use of ADT as well as information regarding the diagnosis of CRPC, prescription of and effectiveness of each systemic therapy and survival outcomes. Additionally, factors that influence decision making around systemic treatment selection and the rationale for changes in treatments are captured. Primarily, data from ePAD will be used to determine the real-world patterns of care amongst Australian oncologists, urologists and radiation oncologists treating prostate cancer allowing comparisons between specialties, centres and between public and private practice settings. Additionally, data from ePAD may be used to analyze clinicopathological factors that predict benefit from each systemic therapy, thereby assisting in determining the optimal sequence of treatments for individual patients.
Sponsors
Walter & Eliza Hall Institute of Medical Research
Eligibility
Sex/Gender
Male
Healthy volunteers
No
Inclusion criteria
Patients eligible for enrolment onto ePAD must meet the following criteria: - Patients of any age and any ECOG performance status - Diagnosis of metastatic HSPC OR - Diagnosis of CRPC, with or without metastatic disease - Histological or cytological confirmation of prostate cancer diagnosis and confirmation of castration-resistance o Histological confirmation of disease is not required in the case of PSA>50 at initial diagnosis - No previous systemic therapy for metastatic castration resistant disease, or patients must be initiating 1st line therapy in the mCRPC setting (i.e. patients who have yet to receive treatment for mCRPC are eligible; additionally, patients who have recently started 1st line treatment for mCRPC are also eligible) o Prior first generation anti-androgens are allowed
Exclusion criteria
Exclusion criteria for ePAD include: - Patients who have received more than two lines of therapy for CRPC already - Patients who are not eligible for treatment (chemotherapy or targeted therapies) subsidized by the PBS
Outcome results
None listed