Bladder, Urothelial and Penile Cancer (BUP) Subcommittee




Bladder, Urothelial and Penile Cancer (BUP) Subcommittee




Bladder, Urothelial and Penile Cancer (BUP) Subcommittee




Bladder, Urothelial and Penile Cancer (BUP) Subcommittee: Dickon Hayne and Shomik Sengupta


Dickon Hayne



Shomik Sengupta

DEPUTY CHAIR (until March 2023)

We would like to take this opportunity to provide an update on the activities and advancements made in the past year. Many thanks to Shomik Sengupta for his long service as the BUP sub-committee deputy chair and welcome to Andrew Weickhardt who will be taking over this role moving forward.

Trial Updates

BCG+MM Accrued

This study reached accrual on 17/05/2023 with 501 patients recruited. Dickon Hayne presented the study at the EAU meeting held in Milan in March 2023 and it will be also presented at ASCO.


This study completed accrual with 28 patients. The clinical results were presented in a poster at ESMO in 2022, and the manuscript was submitted to European Urology in April 2023. Translational research is also currently underway, testing samples from 46 patients with/without recurrence.

BCGMM+N803 sub‐study

Efforts are ongoing to develop a sub-study on N803 (IL-15 superagonist). Unfortunately due to a current lack of FDA approval related to manufacturing issues, this will be on hold until the issue is resolved – estimated another 6 months.

Below the Belt Funded Projects

ACCEPT‐U ANZUP Co‐operative multi‐centre cystectomy database

The database is collecting cystectomy data, and in future will also collect clinical, surgical and outcome data. New data from 299 patients at St. John of God Murdoch in Perth have been recently incorporated, bringing the total number of patients to over 500. A manuscript will be developed during 2023. A new data set for upper tract urothelial carcinoma has been developed and will be coming on line in the very near future.

The Exercyst Trial: Exercise Medicine Prior to Open Radical Cystectomy: Feasibility and Preliminary Efficacy

The manuscript of this study has been published in Medicine and Science in Sports and Exercise.


WAter or Chemotherapy to prevent Urothelial carcinoma a pre‐imPlantation (WACUP) and Feasibility of Water Irrigation post TURBT for NMIBC

The manuscript with pilot study findings is under review for publication. A grant application for a randomised study has been submitted to NHMRC, and we are awaiting the outcome.

Genomic & immunological predictors of response to intravesical therapy

Ongoing research is being conducted on immunological and genomic aspects, and it is anticipated that genetic sequencing data will be available soon.

SUBDUE‐1: SUB‐urothelial Durvalumab InjEction‐1

A total of 11 patients were recruited, and the data was presented at the EAU meeting in March 2023. The main findings of the study were that durvalumab was safe with no immune‐related side effects; durvalumab increased levels of M2 macrophages in mixed/basal more than luminal tumours.

ZIPUP – ZIrconium‐Girentuxiamb PET in Urothelial Cancer Patients

A total of 9 out of 20 patients have been recruited as of 31 March 2023. The study was presented in the ‘trials in progress’ session at EAU.

Underlying Mechanisms of Chemoimmunotherapy Synergism in Non‐Muscle Invasive Bladder Cancer (NMIBC)

Testing samples from 46 patients with recurrence treated with BCG or BCGMM against 15 biomarkers. Early results have suggested 2 biomarkers which are non-predictive, 2 predicting overall prognosis and 2 predicting an improved response to combination therapy.  The research team is also working on immune cell analysis, which includes CD4, CD8, and T-cell subsets.

SUBTEZO 1.2 (formerly SUBDUE‐2): A Phase I/II Trial of SUB‐urothelial aTEZOlizumab injection in patients with BCG‐unresponsive high‐risk, non‐muscle‐invasive bladder cancer

Roche will not be supporting this study ongoing.

Program of ANZUP trials to validate ctDNA biomarker approach

An investigator grant has been secured for this work and draft protocols are being written on detection of ctDNA in urine for observational and randomised studies.

MEMENTO: What are the barriers and facilitators to interdisciplinary models of person‐centred supportive care in the context of penile cancer? A mixed methods study

Members are encouraged to promote recruitment to MEMENTO.

Idea Generation Workshops

The idea generation workshops (IGWs) are designed to facilitate and support those members who have an idea they would like to put forward for discussion and, if supported, to further develop into a future grant application.

The BUP idea generation workshop was held on 13 May 2022 at Sydney Pullman Airport and had 3 concepts presented and over 32 people attended.

We are eager to witness the advancement of BUP concepts and trials in the upcoming year, and we hope for the possibility of conducting face-to-face meetings and events. We thank all those who have attended or contributed to the BUP subcommittee meetings.