2019 Below the Belt Research Fund recipients and studies
 
Andrew Moe - SUBDUE – 1 SUB-urothelial DUrvalumab InjEction - 1 

Our research group is aiming to create a new treatment for patients with bladder cancer. 

Durvalumab is a medicine that targets the body’s immune cells to help combat bladder cancer. When given intra-venously, durvalumab has proven effective at slowing advanced bladder cancer that has spread to other organs.

We will recruit patients with bladder cancer who are recommended to have their bladder removed.


Ben Tran - CLIMATE: Assessing the Clinical utility of miR-371 as a marker of residual disease in Clinical Stage 1 Testicular Germ Cell Tumour, following orchidectomy

Testicular germ cell tumours (TGCT) are highly curable, even in the metastatic setting where platinum-based chemotherapy is highly effective. Patients diagnosed with clinical stage 1 (CS1) disease are most likely cured following orchidectomy, however, up to 50% do develop recurrence and require intensive courses of curative chemotherapy. A short, less toxic course of adjuvant chemotherapy can be used to reduce the risk of recurrence, but at a significant risk of over treating the large group of patients who will never recur. 

CLIMATE is an innovative registry-based translational clinical trial in TGCT that will generate preliminary data demonstrating the clinical utility of miR-371 in CS1 disease. CLIMATE will enrol CS1 patients recommended for active surveillance, test for miR-371 at predefined timepoints and correlate these findings with recurrence, leveraging prospectively collected clinical data within iTestis, a national testicular cancer registry. 

Carole Harris - What, where, when and how long? Using PBS data to understand patterns of care and survival in Australian patients treated for metastatic clear cell kidney cancer 

Our study will describe how medications are used across Australia to treat advanced kidney cancer: which drugs, in which order and for how long. We will understand how long people live with these therapies and if there are sequences of treatment that appear to work better. This study has the advantage that it can look at how cancer therapies are used and how effective they are at a population level. 

Our future aim will be to use this “linkage data” method as the backbone of real-world clinical trials, where ANZUP members in every hospital in Australia can take part, not just those of us lucky to be in hospitals with many research resources. Real world clinical trials make small changes in the way we use standard treatments, and can have big impacts to improve patients’ outcomes.
 
 
Craig Gedye - AdapTax: feasibility, acceptability and safety of adaptively dosed docetaxel 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.

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 a standard chemotherapy called docetaxel, and if it works to take breaks off the chemo, using it for long enough to control the cancer, but then stopping and saving it 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 the chemo treatment, using an effective treatment in more sparingly is hoped to spread the benefit over a longer period of time, without any more side-effects.
 
Kate Mahon - Randomised trial of biomarker-driven intermittent docetaxel versus standard-of-care (SOC) docetaxel in metastatic castration-resistant prostate cancer (mCRPC)

In Australia last year, over 3,000 men died from prostate cancer and many more are living with this disease. Chemotherapy in the setting of prostate cancer which has spread to other parts of the body improves symptoms and survival, however, chemotherapy is associated with significant side effects. 

The standard way to deliver chemotherapy is to continue on a 3 weekly schedule while the cancer is still responding but this is often limited by an accumulation of side effects. Several small studies have suggested that some patients can safely have breaks in chemotherapy with less side effects and a better quality of life. 

However, this is difficult to achieve with our current monitoring strategies. We have developed a new blood test which can accurately identify patients who are responding to chemotherapy. We plan to use this blood test to guide breaks in chemotherapy to provide more tolerable treatment and ultimately improve patients' quality of life.
 

Shomik Sengupta - Genomic & immunological predictors of response to intravesical therapy 

Many bladder cancers are treated with medications put into the bladder in order to prevent them the cancers from growing further into the bladder wall. In some cases, these treatments do not work as they are meant to. At present, we do not know when the treatments might fail. The aim of this study is to assess bladder cancer samples to identify changes within them that may predict whether the commonly used treatments will work or not.
 

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.


Shomik Sengupta - Feasibility of water irrigation post TURBT for NMIBC

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.


2017 Below the Belt Research Fund recipients and studies
 

Camille Short 

Delivering personalised and evidence-based exercise support to men with metastatic prostate cancer via the internet - A pilot RCT examining intervention impact on behaviour change and quality of life

Both physical activity and psychological support can greatly improve quality of life for men with metastatic prostate cancer. Although it is suggested men are more likely to follow physical activity guidelines than utilise psychological support, traditional supervised exercise is often unavailable and/or underutilised. The key is ensuring physical activity is accessible and affordable, but also individualised, evidence-based and safe. This study will provide personalised physical activity advice through an innovative web-based platform. It will be evaluated to ensure it works as intended and is well received by users and has the potential for significant impact through increased reach and uptake.

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Despite the high morbidity experienced by men with metastatic prostate cancer, and evidence that unmet supportive care needs are higher in this group compared to patients with localised disease (Couper et al, 2010; Sanda et al, 2008), there has been little intervention research aiming to improve quality of life and functional capacity for these patients. Where interventions have been trialled, the focus has predominantly been on psychological interventions, and many of these have had limited success (Chambers et al, 2017).

One potentially promising intervention is physical activity support. Physical activity has been shown to improve both the physical and mental health of men with metastatic prostate cancer (Bourke et al, 2014; Cormie et al, 2013; Moe et al, 2017). It has also been suggested that men may be more likely to adhere to physical activity interventions than psychological interventions, since the performance of physical activity and the outcomes associated with it (building strength and endurance) align with traditional masculine values (Galvao et al, 2016). However, a key challenge is providing physical activity support to men in a way that is easily accessible and affordable, while also individualised, evidence-based and safe. This novel study will address this issue by providing evidence-based physical activity advice through an innovative web-based platform.

While there are some face-to-face programs available, many men live too far away, are too unwell or lack funds to attend face-to-face sessions, especially on an ongoing basis. Our research team, which consists of experts in prostate cancer, exercise physiology, psychology, medicine and telehealth is well placed to develop an alternative support system that will be available to men with metastatic disease via the internet.

Once the website is developed the next step will be to conduct preliminary research to ensure it works as intended and is well received by the initial users.

Megan Crumbaker & Anthony Joshua 

Bipolar androgen therapy (BAT) in men with metastatic castrate-refractory prostate cancer

This study will test the benefit of monthly testosterone injections for metastatic prostate cancer (cancer which has spread outside the prostate) patients on long-term testosterone reducing drugs. Benefits may include an anti-cancer effect, improvements in quality of life and potential for cancer cells to respond positively to drugs that have failed previously. The research will test the possible benefits and increase understanding about this treatment. Additionally, the study aims to improve the ability to select patients who can benefit most from this treatment due to changes in their tumour that might make them more responsive. 

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Androgen deprivation therapy (ADT) remains the mainstay of prostate cancer treatment. Though an effective therapy initially, the side effects of ADT are numerous and treatment resistance is inevitable. Castrate-refractory prostate cancer (CRPC) progresses via adaptive mechanisms that allow ongoing androgen receptor (AR) signaling despite castrate levels of androgens. Preclinical data suggest these adaptive mechanisms may be exploited through the administration of supraphysiologic levels of testosterone, which has been shown to inhibit growth in some androgen-receptor expressing prostate cancer cells. Men with germline and/or somatic DNA repair defects may be particularly sensitive to this treatment.

This study aims to explore the effect of bipolar androgen therapy (BAT) with testosterone enanthate on PSA responses in men with advanced castrate-refractory prostate cancer (CRPC) and DNA repair defects identified on screening circulating tumour DNA (ctDNA) or tumour biopsy.

The research will test the hypothesis while information on treatment effects may be key to appropriate patient selection.

Lisa Horvath 

Statins in Metastatic Castration-Resistant Prostate Cancer (CRPC)

It has been found that certain levels of specific circulating lipids (naturally occurring molecules) in blood are associated with a worse prognosis in men with metastatic castrate-refractory prostate cancer (cancer which has spread to other parts of the body and is able to grow despite hormone therapy). The purpose of this study is to find out if a course of a drug called simvastatin (commonly used to treat high cholesterol, heart disease and diabetes) will lower the specific circulating lipids in blood associated with a worse prognosis.

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To date, biomarker studies in CRPC have mainly focused on changes in the cancer and their effects on therapeutic resistance and prognosis. However, the host environment (i.e. the patient) and its interactions with cancer is increasingly important, in light of the association of prostate cancer and obesity. Our exploratory study was the first to profile the plasma lipidome of men with metastatic CRPC, and to identify and validate plasma lipidomic profiles that are associated with survival in CRPC (Lin et al, Int J Cancer, 2017).

Unsupervised analysis of baseline lipidomic profiles classified patients of a Phase 1 discovery cohort into two groups with significant survival differences (HR 2.31, 95% CI 1.44-3.68, p=0•0005), independent of chemotherapy response. The baseline levels of 46 lipids were individually prognostic, and predominantly sphingolipids. A prognostic three-lipid signature was derived, consisting of ceramide, sphingomyelin and phosphatidylcholine. This signature was associated with shorter overall survival in the Phase 2 cohort (HR 4.8, 95% CI 2.06-11.1, p=0.0003), and was an independent prognostic factor when modelled with clinicopathological factors or metabolic characteristics (Lin et al, Int J Cancer, 2017).

Therefore, a key question is whether therapeutic modulation of a patient’s lipid profile will improve prognosis. However, the first step is to see if lipid modulation therapy can change the circulating lipidomic profile in CRPC patients.

Statins significantly reduces the plasma levels of ceramides, sphingomyelin and cholesterol in those with cardiovascular disease or metabolic syndrome, suggesting that this therapy could change the high risk circulating lipid profile of CRPC patients.

The aim of this study is to assess whether treatment with simvastatin during docetaxel chemotherapy for metastatic CRPC can reverse a poor prognostic circulating lipid signature.

Haryana Dhillon

Patient perception of adherence to treatment advice in urogenital and prostate cancers: a qualitative exploration

It is important people with urogenital and prostate cancers complete their planned treatment and follow-up. However little is known about how this is for patients and how we can help them complete their treatments. We will explore patients’ thoughts about the advice they have been given and what may help or hinder their ability to adhere to treatment advice. We will use this information to develop better support to help patients complete treatments and improve clinical outcomes.

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To achieve optimal patient and disease outcomes in urogenital and prostate cancers it is important patients complete the planned course of anti-cancer treatment(s) and continue regular follow-up and disease surveillance. Adherence to supportive care intervention advice has the potential to alleviate symptoms and ensure that patients are able to complete planned anti-cancer treatment. However, at present little is known about what patients are told about adherence and their perception of this advice. We know little about the barriers and facilitators to adherence to treatment advice in the cancer setting.

It is recognised that treatments resulting in a high side-effect and symptom burden over a prolonged duration of use are likely to result in lower adherence. Risk factors for lower adherence to treatment have been identified more generally in the healthcare literature, including lower literacy, lower health literacy, comorbid illness, and poly pharmacy. However, these factors have not been assessed within urogenital and prostate cancer populations.

This study aims to explore patient adherence to treatment (anticancer, supportive care, follow-up) advice across urogenital and prostate cancers.

Dickon Hayne 

ANZUP co-operative multi-centre cystectomy database (ACCEPT)   

Removal of the bladder as treatment for bladder cancer may be necessary to cure the disease. However this remains one of the most major procedures performed by urologic surgeons and carries significant risks for patients. Despite this, there is a currently a lack of quality research to identify ways to improve patient outcomes. The purpose of this study is to set up Australia’s first national secure online database to allow investigators to analyse treatments currently used by urologists and their associated outcomes and complications after bladder removal. This information will then be used to formulate future randomised controlled trials.

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Radical cystectomy involves significant risk of morbidity and mortality. The risk of any complication is significantly more than 50% and recent reported mortality ranges between less than 1% and more than 8%.[ref] Specific complications after radical cystectomy from previous studies include infection (25%)4, intestinal obstruction (23%)4, wound complications (15%)4, thromboembolic events (8%)4, intestinal anastomotic leakage (3%)2. Other complications include significant bleeding, lymphocoele formation, and erectile and sexual dysfunction [ref]. The primary objective is to create a bi-national (Australia and New Zealand) prospective clinical audit to collect data on outcomes after radical cystectomy surgery and secondarily to hypothesise from acquired data whether specific interventions may achieve improved peri-operative care and outcomes for patients.

 
 
Dennis Taaffe 

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

Bladder removal surgery as a treatment for bladder cancer is associated with high complication and hospital re-admission rates, as well as significant risk of morbidity and mortality. This risk is increased for patients with poor physical fitness or overall function. This study will test the benefits of a supervised four-week pre-surgery strength and aerobic exercise program in improving post-surgery outcomes and quality of life. It is the first Australian study to test the feasibility and preliminary effectiveness of pre-surgical exercise with opportunities to then proceed to a larger multicentre Phase III trial.

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Bladder cancer has a poor 5-year survival rate of 53% compared to other common cancers such as prostate and breast cancer (AIHW, 2017). For those with muscle-invasive bladder cancer the primary treatment is radical cystectomy (RC) which involves the surgical removal of the bladder with lymph node dissection and urinary diversion, and a hospital stay of 1-2 weeks. However, RC is a complex, technically demanding and high-risk surgical procedure which is associated with significant morbidity, readmission rates, and mortality (Smith et al., J Urol 2014). Patients with poor pre-operative cardiopulmonary capacity have a higher risk of complications post-surgery and increased hospital length of stay (Prentis et al., BJU Int 2013). Moreover, given the age of the patients (median age at diagnosis is 76 years) as well as the fact that smoking is a major risk factor, patients may have associated pulmonary and cardiovascular diseases which contribute to poorer overall function and quality of life. As a result, enhancing functional capacity prior to RC may reduce the stress of surgery and attenuate the general deconditioning process in the immediate post-surgical period which may reduce the length of hospital stay, complications, and time to return to usual activities.

However, little information is available regarding the feasibility of pre-surgical exercise or the potential beneficial effect that exercise may have prior to surgery in this patient group. Therefore, we propose to undertake a short-term (up to 4 weeks in duration) feasibility and preliminary efficacy exercise trial in men and women scheduled to undergo RC and follow them for 3 months post-surgery. The exercise program will be supervised and consist of resistance and aerobic training undertaken three times per week.

 
 
Ben Tran 

iTestis: Bioinformatics for Testis Cancer

iTestis is a user-friendly, multi-disciplinary, web-based testicular cancer database. Data collected within iTestis will provide an accurate description of current Australian practices, facilitate retrospective data research projects, seek to answer biological research questions and provide a platform for registry-based trials. It will also record tissue location information from germ cell tumour patients treated in Australia. Once established, iTestis will become a valuable resource to the wider germ cell tumour community.

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While it is the most common cancer in young men, germ cell tumours (GCT) are rare compared to other cancers. Subsequently, in many instances, enrolling sufficient numbers of patients onto clinical trials is not possible. As a result, clinicians often look to data from retrospective studies undertaken by large international centres to answer these questions. While Australia’s reputation in GCT research remains strong through the leadership of the Germ Cell Subcommittee, the decentralisation of cancer treatment in Australia has made it difficult for any single Australian centre to accumulate sufficient numbers of patients to generate any meaningful research, whether that be clinical, retrospective or translational.

iTestis will enable Australia to make large contributions to the G3 global germ cell collaborative group which conducts multiple retrospective data research projects. It may also give us the impetus to lead some of the projects. Some examples of recent G3 projects include: brain mets (led by Darren Feldman) and risk of VTE during chemotherapy (led by Ben Tran).

Selected centres participating in iTestis will gain patient consent for archival tissue collection/analysis and blood collection/analysis to answer biological research questions and facilitate translational research. The availability of tissue or blood will be indicated within iTestis, so that at a later date, when there is a relevant research project, a query can be made to identify eligible patients with available specimens for translational studies (with approval of the investigators involved). Multiple clinically relevant questions can be answered using such a resource. Additionally, the resource can be used to join international collaborations such as the Craig Nichols led miR371 biomarker for stage 1 disease protocol or the Movember GAP5 biomarkers for platinum resistance protocol.

Following the establishment of iTestis as a robust and reliable registry/database, there will also be capabilities to conduct registry-based randomised-controlled trials (RCT). Registry-based RCTs provide comprehensive data across multiple lines of treatment at no additional cost, with the in-built capacity to compare study eligible and ineligible patients enrolled on the registry for a real-world comparison.



 

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