2018 Below the Belt Research Fund recipients and studies
Ben Smith - Development and piloting of a Question Prompt List (QPL) to aid informed treatment decision making in men diagnosed with localised prostate cancer
Every year more than 16,000 Australian men are diagnosed with prostate cancer. Men diagnosed with localised prostate cancer (LPC) face a highly preference-sensitive choice between treatments with similar cure rates but different side effects. We recently found that men choosing between robotic prostatectomy and radiotherapy had varied information and decision-making preferences/needs. They often relied on information and recommendations from their clinicians, but such information was often imbalanced or incomplete. This study will develop and evaluate printed and online versions of a Question Prompt List (QPL) to help men get appropriate treatment information from their preferred source (i.e. treating clinicians) while accommodating diverse preferences regarding the type and amount of information desired.
QPLs are a simple and inexpensive communication tool that have been shown to enhance patient participation in decision-making, improve information recall and reduce anxiety in other oncology settings. A multidisciplinary team including consumers, urologists, radiation oncologists, and psychology researchers will develop the QPL. It will be based on QPLs for other cancer groups, our previous research in this area and reviews of the scientific literature and existing resources for men with LPC. We will determine:
1) Preference for either the printed or online QPL;
2) Acceptability of the QPL to both patients and clinicians;
3) Feasibility of delivering the QPL early in the decision-making process.
We expect that the QPL will be a feasible and acceptable tool for improving treatment decision making in men with LPC. The study will inform the best timing and method for delivering the QPL.
Camille Short - Why do men leave active surveillance? A mixed methods investigation examining factors contributing to adherence on active surveillance
Active surveillance is a treatment option for men with low risk prostate cancer that has not spread beyond the prostate. It aims to delay invasive treatments until the disease progresses to a stage that is more appropriate for active treatment (e.g. surgery or radiotherapy). To detect disease progression, the cancer is monitored regularly using a series of tests, such as blood tests and digital rectal examinations. Research suggests approximately 50% of men will transition from active surveillance to active treatment within two years and that up to 38% of these men do so without evidence of disease progression. However these men’s reasons for moving away from active surveillance are poorly understood, and further research is needed to understand why Australian men opt-out of active surveillance for non-clinical reasons.
This information will be used to develop supportive care tools and interventions to address these factors and men’s needs. This research will be achieved by firstly surveying men who have transitioned from active surveillance to active treatment, and secondly by interviewing men who left active surveillance for non-clinical reasons.
Craig Gedye - EnzAdapt: feasibility, acceptability and safety of adaptive dosing of enzalutamide in men with metastatic castrate-resistant prostate cancer
When prostate cancer spreads, injections that suppress the male hormone testosterone can control the cancer for some time, but it almost always starts to grow again later. Hormone tablets to block testosterone on top of the injections can regain control of the cancer, but again, only for a limited time of about one year. Cancers grow like weeds; some of the cancer cells can be controlled by weedspray but other parts of the cancer aren’t affected and can flourish. These vulnerable and resistant cells of the cancer are often holding each other in balance; and when a treatment is used it can favour one group of cancer cells over another. This trial is designed to test the idea of taking breaks off taking hormone tablets, using them for long enough to control the cancer, but then stopping and saving them up until later to treat the cancer again (and again… and hopefully again and again). While every man’s cancer is predicted to eventually become resistant to hormone treatments, using hormone tablets in a sparing and cunning way is hoped to spread the benefit over a longer period of time, without more side-effects. Very early reports with other drugs support this idea; this will be the first trial testing this idea with enzalutamide (Xtandi). If this idea proves to be sound, it may improve the lives and survival of men with prostate cancer.
Edmond Kwan and Heidi Fettke - Application of a multi-gene prostate circulating tumour DNA (ctDNA) panel in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Currently, one of the major research priorities in prostate cancer involves gaining greater insight into the mechanisms by which the disease becomes resistant to various therapies.
The area of research that focuses on better predicting who will and will not benefit from certain treatments is known as biomarker discovery. In recent years, the interest in using circulating tumour DNA (ctDNA) detected in the blood of patients with prostate cancer as a means of biomarker discovery has grown significantly.
Metastatic hormone-sensitive prostate cancer (mHSPC) is a form of prostate cancer that has spread to other parts of the body, but the tumour cells are still susceptible to testosterone suppression therapy. Efforts to research ctDNA in men with mHSPC has been hampered by the inability to detect the very small amounts of tumour DNA that is present in the bloodstream. As a result, very little is known about the genetic makeup of mHSPC.
We have custom-designed a laboratory test that can reliably detect low amounts of ctDNA in the bloodstream. We wish to perform this test in a group of men with mHSPC, and report on the genetic mutations that are commonly present.
This analysis is critical for furthering our understanding of advanced prostate cancer and improving the outcomes for patients with this disease. Furthermore, lessons learnt from the development and improvement of this test could be used to more accurately analyse patient samples from ANZUP-led clinical studies (e.g. ENZAMET, ENZARAD).
Haryana Dhillon - Assessing the feasibility, acceptability and impact on practice of electronic patient reported outcome assessment of symptoms in people with Genitourinary cancer: a mixed methods study
Patient reported outcomes assessment (PRO), particularly symptoms and side-effects of treatment, integrated into cancer care have been shown to improve quality of life and
survival in people living with a range of cancers. What is unclear is the best way to integrate data collection into cancer care to ensure symptoms are responded to and effectively addressed outside a clinical trial.
We will assess the feasibility and acceptability of PRO assessment to patients and healthcare professionals. To determine the impact of PRO assessment on cancer care and clinical services we will monitor clinical recommendations and treatment changes made in response to PRO reports provided by patients via a self-report app. We will also interview patients, caregivers, and healthcare professionals to develop a deep understanding of the barriers and facilitators to incorporating routine collection of PRO assessment of symptoms in practice.
Completing this pilot study will provide substantial informative data to support future implementation of PRO symptom assessment and the clinical pathways required to provide appropriate care for patients experience symptoms and side-effects of GU cancer and its treatment. Ultimately, this project will support reduction in the undesirable effects of cancer and its treatment and will improve quality of life and quality of survival for those impacted by cancer. In the longer-term, it is expected to reduce the impact of patient symptom and side-effects on the healthcare system by proactively intervening and reducing the costs of care.
Mark Stein - A pilot trial of Exendin PET scanning in metastatic castrate resistant prostate cancer
In a very large diabetes clinical trial, it was observed that fewer people taking a diabetes drug called Liraglutide developed prostate cancer compared with those taking placebo. There is thus interest in testing Liraglutide as a treatment for prostate cancer.
Liraglutide acts on cells through a chemical on the cell surface called a GLP1 receptor.
Exendin PET scans are special nuclear medicine imaging scans which can detect cancers bearing GLP1 receptors on their cells.
However, we are unaware of any reports of the use of Exendin PET scanning in prostate cancer.
In this project, we will enrol men with known prostate cancer and they will have Exendin PET scans. We hope this will demonstrate that prostate cancers can be detected by Exendin PET scans.
If we can demonstrate that, we will have confirmed that prostate cancers bear GLP1 receptors and will have thus fulfilled a precondition for the design of clinical trials to test whether Liraglutide, which works by acting on GLP1 receptors, can treat prostate cancer.
Recurrence after transurethral resection of bladder tumour (TURBT) is a significant clinical problem requiring close follow-up and retreatment. The re-implantation of tumour cells is postulated to be one mechanism of recurrence. A single instillation of chemotherapy agents (commonly Mitomycin) has been shown to be effective in reducing recurrence after TURBT. Nonetheless, practical barriers including availability of drug and nursing expertise mean that this remains under-utilised. There is some evidence that bladder irrigation, particularly using water, which can have an osmotic cytotoxic effect, may be as effective as post-TURBT chemotherapy. This study will determine the safety and feasibility of undertaking water irrigation during and after TURBT, with the aim of progressing to a larger randomised trial.
Suzanne Chambers - QualTheraP: A nested, multi-perspective longitudinal qualitative study of participants in the TheraP trial
There is a need to better understand men and their partners/informal carers' experiences of advanced prostate cancer over time. To date, no study has qualitatively explored the experiences of men with advanced prostate cancer and their partners throughout their involvement in a medical trial. Accordingly, we propose a multi-perspective qualitative longitudinal study nested within the TheraP trial; a trial which compares a new type of advanced prostate cancer treatment, Lu-PSMA, with a type of chemotherapy called cabazitaxel, which is the standard treatment for advanced prostate cancer when other treatments have stopped working. We will interview trial participants after enrolment, at the mid-point of treatment, and on completion of the treatment. We will report motivations for trial participation among men with advanced cancer, common themes of their trial participant experience, and identify needs unique to men within a medical trial.