Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12616000585426
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
6/04/2016
Date registered
Help: Date registered
5/05/2016
Date last updated
Help: Date last updated
9/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/05/2019
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
electronic Prostate Cancer Australian Database
Scientific title
Analyzing Treatment Patterns and Outcomes from Real-World Patients with Advanced Prostate Cancer
Additional trial identifiers [1] 288937 0
None
Universal Trial Number (UTN)
Trial acronym
ePAD Australia
Related trial records

Health condition
Health condition(s) studied:
Advanced Prostate Cancer 298291 0
Condition category
Condition code
Cancer 298420 298420 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of the intervention or exposure
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.
Intervention code [1] 294407 0
Not applicable
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297901 0
To evaluate the presentation, treatments and outcomes of consecutive patients with newly or recently diagnosed prostate cancer (mHSPC or CRPC) managed in routine clinical practice, thereby determining the patterns of care for patients with prostate cancer.
Timepoint [1] 297901 0
The data collection of presentation data will usually occur at the participant's initial visit to clinic. The data will continue to be collected at every follow up visit until death if possible.
Primary outcome [2] 298109 0
To evaluate the treatments of consecutive patients with newly or recently diagnosed mHSPC and CRPC managed in routine clinical practice, thereby determining the patterns of care for advanced prostate cancer patients.
Timepoint [2] 298109 0
The data collection of treatment data will usually occur at the point of participant visit to clinic. Whilst the participant is on treatment, the data will continue to be collected at every follow up visit until treatment is stopped.
Primary outcome [3] 298110 0
To evaluate the treatment outcomes of consecutive patients with newly or recently diagnosed mHSPC and CRPC managed in routine clinical practice, thereby determining the patterns of care for advanced prostate cancer patients.
Timepoint [3] 298110 0
The data collection will usually occur at the point of participant visit to clinic. Progression data, toxicities and survival data will continue to be collected at every follow up visit until death.
Secondary outcome [1] 322573 0
To determine treatment patterns for CRPC in routine clinical practice, including: - Determining the proportion of patients who receive 1st, 2nd, 3rd and subsequent lines of systemic treatment - Determining the proportion of patients who receive secondary hormone treatment versus chemotherapy in 1st line - Determining the impact of age, cardiovascular co-morbidity and performance status on treatment recommendations This is a composite secondary outcome that involves collecting data on treatment patterns to enable comparisons to be made and to analyse the effect of different variables on treatment patterns..
Timepoint [1] 322573 0
The data collection of treatment data will usually occur at the point of participant visit to clinic. Whilst the participant is on treatment, the data will continue to be collected at every follow up visit until treatment is stopped and follow up data will be continued to be collected until death.
Secondary outcome [2] 322574 0
To determine survival outcomes in CRPC managed in routine clinical practice: - Determining the overall survival for all CRPC patients - Identifying novel prognostic factors - Determining the progression free survival for secondary hormone treatment versus chemotherapy in 1st line - Determining the progression free survival for secondary hormone treatment versus chemotherapy in 2nd line - Comparing overall survival for CRPC patients initially treated with secondary hormone treatment versus chemotherapy This is a composite secondary outcome collecting dates of follow up, date of progression and date of death to enable survival analysis of the dataset.
Timepoint [2] 322574 0
The data collection of survival data will usually occur at the point of participant visit to clinic e.g date of follow up visit. Follow up data will be continued to be collected until death. Progression data will be collected at point of patient visit. There will be annual search for patient's death date.
Secondary outcome [3] 322575 0
To explore the role of secondary hormone therapy in changing tumour biology - Determining PSA response rates for cabazitaxel following AA versus docetaxel - Determining the proportion of patients who develop visceral metastases following secondary hormone therapy versus chemotherapy This is a composite secondary outcome comparing different hormonal therapies.
Timepoint [3] 322575 0
The data collection of hormone treatment data will usually occur at the point of participant visit to clinic. Whilst the participant is on treatment, the data will continue to be collected at every follow up visit until treatment is stopped and follow up data will be continued to be collected until death.
Secondary outcome [4] 456544 0
Determining the proportion of patients who upfront systemic therapy in addition to androgen deprivation therapy
Timepoint [4] 456544 0
The data collection of survival data will usually occur at the point of participant visit to clinic e.g date of follow up visit. Follow up data will be continued to be collected until death. Progression data will be collected at point of patient visit. There will be annual search for patient's death date.
Secondary outcome [5] 456545 0
Determining the proportion of patients who receive chemotherapy versus novel antiandrogen therapy or in combination
Timepoint [5] 456545 0
Determining the impact of age, co-morbidities and performance status on treatment recommendations
Secondary outcome [6] 456546 0
Determining the impact of disease-related factors including disease volume, sites of disease and de novo presentation on treatment selection
Timepoint [6] 456546 0
Determining the impact of disease-related factors including disease volume, sites of disease and de novo presentation on treatment selection

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Males
Healthy volunteers
No
Key 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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In order to compare clinical outcomes across different subgroups, Kaplan-Meier survival curves will be defined from survival data and constructed using SAS® statistical software (SAS Institute Inc., Cary, NC, USA). The stratified log rank test will be used to compare survival curves between different groups of participants. Statistical methods such as the Chi-square, Fisher’s exact test and conditional logistic regression will be used to determine the statistical significance of relationships between differing factors. P-values less than 0.05 will be considered significant.
With a current sample size of more than 1000 patients ePAD is the largest known dataset of real world mCRPC patients and this number is sufficient to allow descriptive analyses of the patterns of care within Australia. With expansion to include patient data relating to hormone sensitive setting and from countries within Asia (including Singapore, Taiwan and South Korea), this dataset will allow further meaningful and clinically relevant analyses to inform future patient care.
Patients with incomplete data that is relevant to a statistical analysis will be censored for that particular analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
6/07/2016
Date of last participant enrolment
Anticipated
10/01/2032
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
2372
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 5552 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 5553 0
Western Hospital - Footscray
Recruitment hospital [3] 5555 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 5556 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 5557 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [6] 5559 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [7] 5560 0
Concord Repatriation Hospital - Concord
Recruitment hospital [8] 5561 0
The Canberra Hospital - Garran
Recruitment hospital [9] 5562 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [10] 5563 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [11] 5564 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 5565 0
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [13] 7986 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [14] 10966 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [15] 29041 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [16] 29042 0
Eastern Health - Box Hill
Recruitment hospital [17] 29043 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [18] 29044 0
The Border Cancer Hospital - Albury
Recruitment hospital [19] 29045 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [20] 29046 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [21] 29047 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [22] 29048 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 15962 0
3220 - Geelong
Recruitment postcode(s) [2] 22754 0
3350 - Ballarat Central
Recruitment postcode(s) [3] 45322 0
3000 - Melbourne
Recruitment postcode(s) [4] 45323 0
3128 - Box Hill
Recruitment postcode(s) [5] 45324 0
3550 - Bendigo
Recruitment postcode(s) [6] 45325 0
2640 - Albury
Recruitment postcode(s) [7] 45326 0
4101 - South Brisbane
Recruitment postcode(s) [8] 45327 0
2305 - New Lambton Heights
Recruitment postcode(s) [9] 45328 0
2298 - Waratah
Recruitment postcode(s) [10] 45329 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 293289 0
Commercial sector/Industry
Name [1] 293289 0
Astellas Pharma Australia Pty Ltd
Country [1] 293289 0
Australia
Funding source category [2] 293291 0
Commercial sector/Industry
Name [2] 293291 0
Janssen-Cilag Pty Ltd
Country [2] 293291 0
Australia
Funding source category [3] 302734 0
Commercial sector/Industry
Name [3] 302734 0
Amgen Australia Pty Ltd
Country [3] 302734 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Walter & Eliza Hall Institute of Medical Research
Address
1G Royal Parade
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 292092 0
None
Name [1] 292092 0
Address [1] 292092 0
Country [1] 292092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294763 0
Melbourne Health HREC
Ethics committee address [1] 294763 0
Ethics committee country [1] 294763 0
Australia
Date submitted for ethics approval [1] 294763 0
25/11/2015
Approval date [1] 294763 0
15/01/2016
Ethics approval number [1] 294763 0
HREC/15/MH/352

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64966 0
Dr Ben Tran
Address 64966 0
Medical Oncology Peter MacCallum Cancer Centre 305 Grattan Street Parkville VIC 3000
Country 64966 0
Australia
Phone 64966 0
+61 3 8559 7882
Fax 64966 0
+61 3 8559 7739
Email 64966 0
[email protected]
Contact person for public queries
Name 64967 0
Michael Harold
Address 64967 0
Gibbs Lab WEHI Level 8 East Main Building Royal Melbourne Hospital 300 Grattan Street Parkville VIC 3050
Country 64967 0
Australia
Phone 64967 0
+61 3 9345 2799
Fax 64967 0
+61 3 9345 2317
Email 64967 0
[email protected]
Contact person for scientific queries
Name 64968 0
Ben Tran
Address 64968 0
Medical Oncology Peter MacCallum Cancer Centre 305 Grattan Street Parkville VIC 3000
Country 64968 0
Australia
Phone 64968 0
+61 3 8559 7882
Fax 64968 0
+61 3 8559 7739
Email 64968 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is a data registry that has data collected with a waiver of patient consent and all data shared for research or audit is done in a aggregated summary form and no individual data is available.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.