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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]

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

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Single assessment at time of enrolment

Primary outcome [2]

PROCAP Change in HRQOL after systemic treatment for mHSPC for CALD vs non-CALD

Timepoint [2]

Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.

Primary outcome [3]

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]

Single assessment at time of enrolment

Secondary outcome [1]

HOROSCOPE Both Cohorts (mHSPC and Localised cohorts): Prevalence of HRR alterations in tested population

Timepoint [1]

Single assessment at time of enrolment

Secondary outcome [2]

PROCAP Explore the CALD indicator responses and classify CALD subgroups that are represented in the mHSPC population

Timepoint [2]

Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.

Secondary outcome [3]

HOROSCOPE Cohort A (mHSPC): Time to castration resistance

Timepoint [3]

From initiation of androgen deprivation therapy (ADT) to development of castration resistance, up to 5 years

Secondary outcome [4]

HOROSCOPE Cohort A (mHSPC): Time to treatment failure

Timepoint [4]

From initiation of first-line systemic therapy to discontinuation due to disease progression or adverse events, up to 5 years

Secondary outcome [5]

HOROSCOPE Cohort A (mHSPC): Overall survival each by HRR molecular sub-groups

Timepoint [5]

From diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC) to death from any cause, up to 5 years

Secondary outcome [6]

HOROSCOPE Cohort B (unfavorable-intermediate, high/very-high risk localised): Recurrence free survival

Timepoint [6]

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]

HOROSCOPE Cohort B (unfavorable-intermediate, high/very-high risk localised): Metastasis free survival

Timepoint [7]

From date of diagnosis to first evidence of distant metastasis, up to 5 years

Secondary outcome [8]

HOROSCOPE Cohort B (unfavorable-intermediate, high/very-high risk localised): Time to next treatment in localised prostate cancer patients

Timepoint [8]

From completion of initial treatment to commencement of any subsequent therapy up to 5 years

Secondary outcome [9]

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]

From date of diagnosis to initiation of first systemic therapy up to 5 years

Secondary outcome [10]

PROCAP Differences in patient experience after systemic treatment for mHSPC between CALD and non-CALD patients

Timepoint [10]

Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.

Secondary outcome [11]

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]

Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.

Secondary outcome [12]

PROCAP Changes in patient experience across treatment for mHSPC patients in overall cohort and by CALD vs non-CALD status

Timepoint [12]

Assessed at time of enrolment (baseline), and 6, 12, 24 months post-enrolment.

Secondary outcome [13]

PROCAP Changes in patient experience across treatment for mHSPC patients in overall cohort and by CALD vs non-CALD status

Timepoint [13]

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?

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]

Charities/Societies/Foundations

Name [1]

MOVEMBER

Address [1]

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

AstraZeneca

Address [2]

Country [2]

Australia

Funding source category [3]

Commercial sector/Industry

Name [3]

Pfizer

Address [3]

Country [3]

United States of America

Primary sponsor type

Other

Name

Walter and Eliza Hall Institute of Medical Research

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Melbourne Hospital Human Research Ethics Committee

Ethics committee address [1]

https://www.thermh.org.au/research/researchers/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/11/2024

Approval date [1]

19/02/2025

Ethics approval number [1]

Summary

Brief summary

What is the purpose of this research?
The PROXIMITY study is a national, multi-site research project aiming to better understand how prostate cancer develops, progresses, and responds to treatment. By collecting clinical data, patient-reported outcomes, and optional biological samples, the study seeks to improve the care and outcomes of men with prostate cancer.

The study follows a master protocol, with flexible sub-studies introduced over time to address specific research questions. This registration describes the overall PROXIMITY study and its first two sub-studies: HOROSCOPE and PROCAP.

Who can take part?
You may be eligible to participate if you are aged 18 years or older and have been diagnosed with prostate cancer. Each sub-study will have its own eligibility criteria to determine who can take part.

What’s involved?
If you agree to take part, depending on your eligibility and consent for specific sub-studies, you may be asked to:

Allow researchers to access your prostate cancer-related medical records

Complete online surveys about your health, symptoms, and quality of life

Optionally provide blood or tissue samples, if available via your treating team

Participation in the PROXIMITY master study allows for the possibility of being invited to future sub-studies over the 10-year study period. You can choose to join any sub-study you are eligible for given they would be available at your treating site.

What are the sub-studies about?

HOROSCOPE investigates how changes in specific DNA repair genes (such as BRCA1, BRCA2, and other homologous recombination repair genes) affect treatment outcomes in patients with metastatic or high-risk localised prostate cancer. This involves retrieving archived tissue for genomic testing—no extra visits or procedures are required.

PROCAP looks at how cultural background and language preferences influence prostate cancer care. It involves completing surveys over a 2-year period to understand how different patient experiences and backgrounds may impact care and quality of life.

Please note: All PROXIMITY sub-studies are observational only. No treatments are provided through participation.

Why is this research important?
Your participation will help researchers understand the diverse experiences of men with prostate cancer, including how different treatments affect quality of life. The findings may lead to more personalised, culturally responsive care in the future.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Ben Tran

Address

The Walter and Eliza Hall Institute of Medical Research (WEHI) 1G Royal Parade, Parkville, Victoria, 3052, Australia

Country

Australia

Phone

+61 03 8559 7810

Fax

[email protected]

Contact person for public queries

Name

Elizabeth Diao

Address

The Walter and Eliza Hall Institute of Medical Research (WEHI) 1G Royal Parade, Parkville, Victoria, 3052, Australia

Country

Australia

Phone

+61 03 8559 7810

Fax

[email protected]

Contact person for scientific queries

Name

Ben Tran

Address

The Walter and Eliza Hall Institute of Medical Research (WEHI) 1G Royal Parade, Parkville, Victoria, 3052, Australia

Country

Australia

Phone

+61 03 8559 7810

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically