Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000585426
Ethics application status
Approved
Date submitted
6/04/2016
Date registered
5/05/2016
Date last updated
17/02/2021
Date data sharing statement initially provided
9/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prostate Cancer Registry collecting treatment data on patients with Castrate-Resistant prostate cancer to investigate the outcomes of these treatments.
Scientific title
Analyzing Treatment Patterns and Outcomes from Real-World Patients with Castrate-Resistant Prostate Cancer (CRPC)
Secondary ID [1] 288937 0
None
Universal Trial Number (UTN)
Trial acronym
ePAD Australia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Castrate-Resistant 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 intervention(s) / exposure
The proposed electronic CRPC Australian database (ePAD) is a multi-site, national prospective cohort study that will collect data regarding baseline patient characteristics, details at diagnosis, pathological characteristics, details regarding local treatment and use of Androgen deprivation therapy, details regarding diagnosis of castration-resistance, prescription of and effectiveness of each systemic therapy and survival. Additionally, factors that influence decision making around systemic treatment selection and the rationale for change of treatments will be captured.
Participants will be followed up until death and if lost to follow up will be censored at date last visit for analysis purposes. All data on participants will be sourced in the clinic or from medical records.
Primarily, data from ePAD will be used to determine the patterns of care amongst Australian oncologists, urologists and radiation oncologists, and allow comparisons across each group,
Intervention code [1] 294407 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297901 0
To evaluate the presentation of consecutive patients with newly or recently diagnosed CRPC managed in routine clinical practice, thereby determining the patterns of care for CRPC patients.
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 CRPC managed in routine clinical practice, thereby determining the patterns of care for CRPC 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 CRPC managed in routine clinical practice, thereby determining the patterns of care for CRPC 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.

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 CRPC, with or without metastatic disease
- Histological or cytological confirmation of prostate cancer diagnosis and confirmation of castration-resistance
* 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 or 2nd 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 or 2nd line treatment for mCRPC are also eligible)
* First generation anti-androgens are allowed prior to enrolment
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for ePAD include:
- Patients who have received more than two lines of therapy 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
n order to compare clinical outcomes across different subgroups, Kaplan-Meier survival curves will be defined from survival data and constructed using SAS 'Registered Trademark' software. The stratified log rank test will be used to compare survival curves between different groups of participants. P-values of 0.05 will be considered significant.
Interim analyses:
Planned after enrolment of 100 patients (anticipated to be ~15 months after project initiation) to assess data quality, proportion of older or less fit patients enrolled, variation in treatment regimens used across sites, and progression free and overall survival.
Prevention of skewed data:
To prevent enrolment of a large number of patients from a single site skewing data such that overall results are not representative of widespread community practice, contributions from any one centre will be limited to a maximum of 20% of the total 800 patients.
The sample size of 800 patients will be the largest known dataset of real world mCRPC patients and this number was thought to be sufficient to allow descriptive analyses of the patterns of care within Australia.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
6/07/2016
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
707
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] 5554 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 5555 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 5556 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 5557 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [7] 5558 0
Westmead Hospital - Westmead
Recruitment hospital [8] 5559 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [9] 5560 0
Concord Repatriation Hospital - Concord
Recruitment hospital [10] 5561 0
The Canberra Hospital - Garran
Recruitment hospital [11] 5562 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [12] 5563 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [13] 5564 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 5565 0
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [15] 7986 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [16] 10966 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 15962 0
3220 - Geelong
Recruitment postcode(s) [2] 22754 0
3350 - Ballarat Central

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
Office for Research
Level 6 East
Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
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
Purpose:
The primary purpose of this study is to develop an electronic castrate-resistant prostate cancer (CRPC) Australian database called ePAD. The data from this will then be used to evaluate the patterns of care for Australians with CRPC.

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:
All participants enrolled in this study will have data collected at baseline and ongoing clinic visits. Follow up data will continue to be collected after the completion of patient enrolment which is anticipated to run until September 2019. Data collected will include patient characteristics, details regarding local treatment and use of androgen deprivation therapy, details regarding diagnosis of castration-resistance, prescription of and effectiveness of each systemic therapy and survival. Additionally, factors that influence decision-making around systemic treatment selection and the rationale for change of treatments will be collected. Data will be collected from clinic visits or from medical records. It is hoped that the findings of this study will allow researchers to determine the patterns of care provided to CRPC patients, and potentially improve knowledge of which treatment options may be the most beneficial for individual patients with CRPC.
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
Mr 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
Dr 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 individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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.