Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000634471
Ethics application status
Approved
Date submitted
17/04/2025
Date registered
17/06/2025
Date last updated
17/06/2025
Date data sharing statement initially provided
17/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
PROXIMITY - PROstate cancer patient eXperIence and Molecular Insights Translational studY: A broad master protocol encompassing two observational sub-studies - HOROSCOPE and PROCAP
Scientific title
Prostate cancer patient experience and molecular insights translational study (PROXIMITY): A broad master protocol encompassing two observational sub-studies - HOROSCOPE and PROCAP
HOROSCOPE - Homologous Recombination Repair alterations and Outcomes in metastatic hormone Sensitive prostate Cancer and high-risk lOcalised Prostate cancEr
PROCAP - Using Patient-Reported Outcome and Experience Measures to Identify and Overcome Disparities in CALD (Cultural and Linguistically Diverse) Patients with Advanced Prostate Cancer
Secondary ID [1] 314217 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROXIMITY - PROstate cancer patient eXperIence and Molecular Insights Translational studY HOROSCOPE - Homologous Recombination Repair alterations and Outcomes in metastatic hormone Sensitive prostate Cancer and high-risk lOcalised Prostate cancEr PROCAP - Using Patient-Reported Outcome and Experience Measures to Identify and Overcome Disparities in CALD (Cultural and Linguistically Diverse) Patients with Advanced Prostate Cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 337121 0
Condition category
Condition code
Cancer 333572 333572 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with histologically confirmed prostate cancer will be enrolled into the PROXIMITY study. PROXIMITY is a prospective, multi-site registry study designed to integrate clinical, molecular, and patient-reported data from men with prostate cancer across Australia.

There are no specific data or samples mandated for the PROXIMITY master protocol itself, and no study-specific follow-up visits are required under the overarching protocol. All additional data collection, biospecimen collection, or patient visits are governed by sub-study protocols.

Participants may be identified retrospectively through existing institutional databases or medical record review, or prospectively enrolled at participating sites depending on site capability and sub-study requirements.

Under the PROXIMITY framework, sub-studies investigate specific translational and patient-centred research questions in relevant sub-populations. Depending on the sub-study, patients may be invited to provide clinical data, complete questionnaires, or provide blood and/or tissue samples.

The overall study duration is up to 10 years. The duration and frequency of follow-up vary by sub-study.

HOROSCOPE sub-study:
HOROSCOPE aims to assess clinical outcomes and treatment patterns among patients with homologous recombination deficiency (HRD), including BRCA1/2 and non-BRCA homologous recombination repair (HRR) gene alterations, in metastatic hormone-sensitive prostate cancer (mHSPC) and high-risk localised prostate cancer. Participants will consent to the HOROSCOPE study, and archived tissue (e.g., diagnostic biopsy) will be retrieved and submitted to a central pathology laboratory for genomic testing. No additional study visits are required.

PROCAP sub-study:
PROCAP explores cultural and linguistic diversity among men with advanced prostate cancer and aims to improve the quality of care. Participants will be asked to complete the Australian Bureau of Statistics (ABS) Cultural and Linguistic Diversity (CALD) indicators, the EORTC QLQ-C30 quality-of-life questionnaire, and the Australian Hospital Patient Experience Question Set (AHPEQS). Surveys are completed at four timepoints: Baseline, 6 months, 12 months, and 24 months post-enrolment. Participants may complete these surveys electronically (via REDCap link sent by email) or in person during routine clinical visits, based on their preference.
Intervention code [1] 330828 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341143 0
HOROSCOPE (metastatic hormone-sensitive prostate cancer): Proportion of patients with undetectable prostate-specific antigen (PSA) at 6 months after androgen deprivation therapy (ADT) initiation, stratified by homologous recombination repair (HRR) gene subgroup.
Timepoint [1] 341143 0
Single assessment at time of enrolment
Primary outcome [2] 341144 0
PROCAP Change in HRQOL after systemic treatment for mHSPC for CALD vs non-CALD
Timepoint [2] 341144 0
Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.
Primary outcome [3] 341612 0
PROXIMITY Evaluate molecular biomarkers for high-risk prostate cancer' and/or 'Incidence of molecular biomarkers and variations in a real-world prostate cancer population as a composite primary outcome
Timepoint [3] 341612 0
Single assessment at time of enrolment
Secondary outcome [1] 446502 0
HOROSCOPE Both Cohorts (mHSPC and Localised cohorts): Prevalence of HRR alterations in tested population
Timepoint [1] 446502 0
Single assessment at time of enrolment
Secondary outcome [2] 446503 0
PROCAP Explore the CALD indicator responses and classify CALD subgroups that are represented in the mHSPC population
Timepoint [2] 446503 0
Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.
Secondary outcome [3] 448422 0
HOROSCOPE Cohort A (mHSPC): Time to castration resistance
Timepoint [3] 448422 0
From initiation of androgen deprivation therapy (ADT) to development of castration resistance, up to 5 years
Secondary outcome [4] 448425 0
HOROSCOPE Cohort A (mHSPC): Time to treatment failure
Timepoint [4] 448425 0
From initiation of first-line systemic therapy to discontinuation due to disease progression or adverse events, up to 5 years
Secondary outcome [5] 448427 0
HOROSCOPE Cohort A (mHSPC): Overall survival each by HRR molecular sub-groups
Timepoint [5] 448427 0
From diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC) to death from any cause, up to 5 years
Secondary outcome [6] 448428 0
HOROSCOPE Cohort B (unfavorable-intermediate, high/very-high risk localised): Recurrence free survival
Timepoint [6] 448428 0
From date of definitive local therapy (e.g. surgery or radiotherapy) to date of biochemical, radiological, or clinical recurrence, up to 5 years
Secondary outcome [7] 448429 0
HOROSCOPE Cohort B (unfavorable-intermediate, high/very-high risk localised): Metastasis free survival
Timepoint [7] 448429 0
From date of diagnosis to first evidence of distant metastasis, up to 5 years
Secondary outcome [8] 448430 0
HOROSCOPE Cohort B (unfavorable-intermediate, high/very-high risk localised): Time to next treatment in localised prostate cancer patients
Timepoint [8] 448430 0
From completion of initial treatment to commencement of any subsequent therapy up to 5 years
Secondary outcome [9] 448431 0
HOROSCOPE Cohort B (unfavorable-intermediate, high/very-high risk localised): Time to first systemic therapy in localised prostate cancer patients by HRR sub-group
Timepoint [9] 448431 0
From date of diagnosis to initiation of first systemic therapy up to 5 years
Secondary outcome [10] 448432 0
PROCAP Differences in patient experience after systemic treatment for mHSPC between CALD and non-CALD patients
Timepoint [10] 448432 0
Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.
Secondary outcome [11] 448433 0
PROCAP Changes in health-related quality of life (HRQOL) and specific domains across treatment for mHSPC patients in overall cohort and by CALD vs non-CALD status
Timepoint [11] 448433 0
Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.
Secondary outcome [12] 448434 0
PROCAP Changes in patient experience across treatment for mHSPC patients in overall cohort and by CALD vs non-CALD status
Timepoint [12] 448434 0
Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.
Secondary outcome [13] 448435 0
PROCAP Changes in patient experience across treatment for mHSPC patients in overall cohort and by CALD vs non-CALD status
Timepoint [13] 448435 0
Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.

Eligibility
Key inclusion criteria
PROXIMITY Eligibility
1) Histologically confirmed prostate cancer, though cases with strong evidence highly suggestive of prostate cancer are also permitted (If histology is not available, must have metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) and elevated PSA) level.
2) Advanced (metastatic) stage disease or diagnosis of localised disease that is more than low risk (as defined by NCCN Guidelines Version 4.2024 Prostate Cancer)
3) Able to provide written consent, unless a waiver of the requirement to consent applies for enrolment onto a specific sub-study
4) Additional sub-study inclusion criteria will be listed in the substudy synopsis to inform specific sub-study participation

HOROSCOPE Eligibility
Cohort A mHSPC
1. Participants greater than or equal to 18 years of age with prostate adenocarcinoma
2. Patients with mHSPC initiating / receiving combination treatment
3. Must be consented on the PROXIMITY Main PICF within 12 months of initiating treatment for mHSPC.
4. Accessible archival tumour tissue with prostate adenocarcinoma

Cohort B unfavorable-intermediate, high/very-high risk localised
1. Participants greater than or equal to 18 years of age with prostate adenocarcinoma
2. Accessible archival tumour tissue with confirmed prostate adenocarcinoma
3. Original diagnosis of localised prostate adenocarcinoma from 2020 onwards, with unfavorable-intermediate, high/very-high risk

PROCAP Eligibility
1. Diagnosed with mHSPC and within 0-4 months of starting systemic therapy;
2. Participants greater than or equal to 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) Known medical condition, or other issue in the opinion of the investigator, that would affect adherence to study requirements
2) Presence of an active second malignancy, excluding resected non-melanoma skin cancer, defined as a malignancy treated with curative intent in the last 6 months or for which the patient is receiving active treatment or has evidence of progression on recent imaging.
3) Additional sub-study specific exclusion criteria will be listed in the sub-study synopsis to inform specific sub-study participation

HOROSCOPE Exclusion
• Histological diagnosis of prostate cancer with neuroendocrine differentiation
mHSPC only: Patients not receiving upfront combination treatment for mHSPC
Localised only: Patients who have received neo-adjuvant treatment prior to radical prostatectomy for localised prostate cancer

PROCAP Exclusion
N/A

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
23/06/2036
Actual
Date of last data collection
Anticipated
30/06/2038
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 318735 0
Charities/Societies/Foundations
Name [1] 318735 0
MOVEMBER
Country [1] 318735 0
Australia
Funding source category [2] 318759 0
Commercial sector/Industry
Name [2] 318759 0
AstraZeneca
Country [2] 318759 0
Australia
Funding source category [3] 318760 0
Commercial sector/Industry
Name [3] 318760 0
Pfizer
Country [3] 318760 0
United States of America
Primary sponsor type
Other
Name
Walter and Eliza Hall Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 321200 0
None
Name [1] 321200 0
Address [1] 321200 0
Country [1] 321200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317348 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 317348 0
Ethics committee country [1] 317348 0
Australia
Date submitted for ethics approval [1] 317348 0
27/11/2024
Approval date [1] 317348 0
19/02/2025
Ethics approval number [1] 317348 0

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

Contacts
Principal investigator
Name 140758 0
A/Prof Ben Tran
Address 140758 0
The Walter and Eliza Hall Institute of Medical Research (WEHI) 1G Royal Parade, Parkville, Victoria, 3052, Australia
Country 140758 0
Australia
Phone 140758 0
+61 03 8559 7810
Fax 140758 0
Email 140758 0
[email protected]
Contact person for public queries
Name 140759 0
Elizabeth Diao
Address 140759 0
The Walter and Eliza Hall Institute of Medical Research (WEHI) 1G Royal Parade, Parkville, Victoria, 3052, Australia
Country 140759 0
Australia
Phone 140759 0
+61 03 8559 7810
Fax 140759 0
Email 140759 0
[email protected]
Contact person for scientific queries
Name 140760 0
Ben Tran
Address 140760 0
The Walter and Eliza Hall Institute of Medical Research (WEHI) 1G Royal Parade, Parkville, Victoria, 3052, Australia
Country 140760 0
Australia
Phone 140760 0
+61 03 8559 7810
Fax 140760 0
Email 140760 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.