Summary
The GenI-AIRSPACE trial aims to understand how genetic testing results influence decisions for people with favourable intermediate-risk prostate cancer. Researchers want to see if these test results can help them to safely recommend active surveillance for those with lower genetic risk or suggest treatment if their cancer is more likely to progress.
You may be eligible for this study if you are aged 18 years or older, have a diagnosis of prostate cancer with no evidence of metastatic disease, and your treating doctor has recommended 'active surveillance' as an alternative to having surgery or radiation therapy now.
Almost half of the new prostate cancers diagnosed each year in Australia are referred to as being of 'favourable intermediate risk'. This classification indicates that progression to treatments such as surgery or radiation can, in some circumstances, be deferred and the cancer safely monitored over time. This classification is based on results from routine tests, including biopsy results, diagnostic tests like bone or CT scans, and prostate specific antigen or PSA blood tests.
About this study
Eligible participants will be randomly assigned to one of two groups: the standard of care treatment group which continue in usual care with their treating doctor, or the genomically informed group who will undergo genetic tests to be classified as either high risk or low risk for their cancer progress. To conduct the genetic tests, the study team will request access to tissue samples from previous prostate cancer biopsies and a fresh 10ml blood sample (about 2 teaspoons) will be collected.
The results of these tests will be provided with no explicit treatment recommendation. Instead, the information will be provided to both the participant and the treating doctor, and any treatment decisions will be made through shared decision-making.
This is a randomised trial, and each participant will have an equal change (50%) of being allocated into each group. The group assignment will be decided by a computer, so neither the participant nor the doctor can choose the group.
Both groups will answer questions about their quality of life at the start of the trial, then every 6 months for a year, and then once a year after that. They will be followed for up to 10 years to see if they start treatment for prostate cancer, whether the disease has progressed, and if it has spread.
It is hoped that findings from this study will help determine the utility of genomic screening in individualising treatment pathways for people diagnosed with intermediate-risk prostate cancer, and help lessen the number of people who get intense treatment, without hurting their long-term health outcomes.