None listed
Conditions
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.
Interventions
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, o
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.
Sponsors
Walter and Eliza Hall Institute of Medical Research
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed