Prostate Cancer Subcommittee
ANNUAL
REPORT 2023
Prostate Cancer Subcommittee
ANNUAL
REPORT 2023
Prostate Cancer Subcommittee
ANNUAL
REPORT 2023
Prostate Cancer Subcommittee: Lisa Horvath and Jarad Martin
Lisa Horvath
CHAIR
Jarad Martin
DEPUTY CHAIR
Prostate Cancer Subcommittee has experienced a remarkably busy and fruitful year. Our dedication and efforts have yielded significant results, which are outlined in detail in the following report.
Updates on Trials (completed recruitment)
ENZAMET
A paper on long-term follow up was accepted and published in the Lancet Oncology. Translational work for this important study continues.
ENZARAD
An interim analysis at 130 events was conducted during the year, and IDMSC recommended that the study should continue. The findings emphasised the need for conventional imaging for long-term follow-up. The next analysis is scheduled at 200 events, which we anticipate should occur in 2024.
TheraP
Biomarker studies will be a focus of the coming year ahead.
Pain-free TRUS B
Pain-free TRUS B trial won the BJUI Global Prize 2023 for article of the year, awarded at the USANZ meeting in Brisbane in February 2022.
ENZA-p ANZUP1901
Recruitment has been completed, and biological sub-studies are presently in progress.
Updates on Recruiting Trials
DASL-HiCaP – ANZUP1801
As of 31 March, the trial was open at 92 sites (including satellite sites), with a total of 965 patients recruited.
UpFrontPSMA
Recruitment will be completed with the enrolment of an additional sixteen patients.
A Retrospective Study of Predictors of Early Metastatic Disease using PSMA PET
A protocol amendment has been submitted to expand eligibility criteria to promote recruitment. Once approved, sites will be contacted to advise of the amendment.
EVOLUTION (Lu-PSMA vs Lu-PSMA+IO)
Recruitment passed the 50% mark during the year.
GUIDE
Fifteen patients were screened, and 3 patients were randomised. All the sites are currently open.
PRIMARY 2
This trial recruited well during the year.
NINJA
This trial almost reached the 50% recruitment mark. Data from pre-cursor study will be presented at ESTRO in May.
ANZadapt
The study obtained HREC approval, and opened during the year.
DIPPER – treatment deintensification after RP
This study received HREC approval and due to open in 2023.
The decision-making process for men with rising PSA post radical prostatectomy after ten years who have metastasis identified after PSMA PET-CT scans
The study has been approved by Uni Syd HREC. Members are asked to promote recruitment among colleagues for the health professional interviews. The team is currently seeking 3-4 sites that are willing to submit the project as an access request or low-negligible risk application to their HREC.
Studies in Start-up
ESSA 010 Study
This study is currently in progress.
HiTech
An abstract is planned to be submitted for ASCO. Currently, 19 out of 21 patients have been recruited, with plans to expand to a national cohort. PFS data has been impressive so far. Biomarker studies will be conducted subsequently.
GenI-AIRSPACE: Genomically Informed Active Surveillance in Favourable Intermediate Risk Prostate Cancer
Funding has been secured for the feasibility phase of the study. The project has been submitted to HREC, and we anticipate it opening later in 2023.
WOMBAT
High-dose testosterone and darolutamide re-sensitisation following asymptomatic PSMA failure on darolutamide (for CRPC). The study has secured funding and we anticipate it opening in 2024.
Substudies
TheraP TR
A second TheraP manuscript is being developed.
ICECaP Health Economic analysis
A poster was presented at ASCO GU 2023. Results of analysis have shown that preventing recurrence earlier has health utilisation and QoL benefits. Further research will use trial data (STAMPEDE, TITAN, SPARTAN, COU-AA 301/302) to test model and validate PSMA-based endpoint and present findings to regulators. In addition, ENZAMET data will be submitted for STOPCAP meta-analysis.
New Concepts
ENZA-LIPID
A grant proposal has been submitted to the Ramsay Foundation.
BSPOKE-CaP
Awaiting costings before a proposal is submitted for funding.
SensAdapt
The team will follow up with potential international collaborators and pharma for funding. Also, the treatment de-intensification study developed by Bernard Tombal has been discussed.
STAMPEDE2
The draft schema for STAMPEDE 2 has been presented. Phase I/II trial of standard of care +/-SABR (with DDR +/- secondary randomisation) vs lutetium (compressed schedule).
Procog
Survey of cognitive changes in people with prostate cancer (77/150 people recruited).
Ideas Generation Workshops
The Ideas Generation Workshops (IGWs) generate a pipeline of new trial concepts and ideas. These concepts might then be progressed through individual working parties with updates to the prostate subcommittee.
Prostate Cancer Subcommittee held an IGW on Friday 17 March 2023 at Pullman Sydney Airport. There were 48 attendees, and 11 concepts were presented and discussed.