ProsTIC clinical trials

Clinical trials enable us to answer questions about what is the role of this new technology in improving patient care.

Peter Mac has been involved in trials of theranostics for more than 20 years and has led pivotal trials in prostate theranostics since 2015. ProsTIC has been established to accelerate our research and expand our portfolio of clinical trials.

If you are a patient and interested in participating in a clinical trial, you should contact your medical specialist who can advise whether you might be suitable for a clinical trial and organise appropriate referrals. 

A selection of clinical trials currently recruiting at Peter Mac including the following:

This trial examines the use of Lu-PSMA in combination with immunotherapy (pembrolizumab) in men with castration-resistant metastatic prostate cancer who have progressed on prior enzalutamide, abiraterone and/or apalutamide. If suitable, men in this trial will be treated with up to 6 cycles of Lu-PSMA and pembrolizumab for up to 35 cycles. 

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This phase 1 study examines the use of Lu-PSMA in combination with a PARP inhibitor (olaparib) in men with castration-resistant metastatic prostate cancer who have progressed on prior novel androgen-receptor targeted agents (enzalutamide, abiraterone and/or apalutamide). Radiation therapy kills cancer cells by damaging DNA. PARP-inhibitors are therapies that kill cancer cells by preventing their ability to repair damaged DNA. In this study we will examine whether PARP-inhibitors may synergize with radiation therapy in killing cancer cells by preventing DNA repair after radiation-induced DNA damage. 

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This phase 2 randomised study is recruiting 140 men with newly diagnosed metastatic prostate cancer at 11 Australian studies. Men must have “high volume” disease defined on a PSMA PET/CT scan. Men will be randomised to the experimental arm (Lu-PSMA followed by docetaxel chemotherapy) or standard-of-care (docetaxel). All men with receive androgen deprivation therapy (ADT). 

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In this study, 20 men with newly diagnosed prostate cancer and high-risk features scheduled to undergo prostatectomy with have 1 or 2 cycles of Lu-PSMA prior to surgery. After each cycle of Lu-PSMA, imaging will be performed to assess how much radiation was delivered to prostate cancer. We will also assess the biochemical, imaging and pathology response to Lu-PSMA.

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This is an open label, randomised, stratified, 2-arm, multicentre phase 2 clinical trial recruiting 160 participants over 12 months and followed until 150 events occurred (approximately another 18 months). Participants will be randomised to enzalutamide or enzalutamide and Lu-PSMA in a 1:1 ratio. A minimisation approach will be used to minimise chance imbalances across the following stratification factors: study site, volume of disease (>20 versus ≤20 sites of disease measured on 68Ga-PSMA PET/CT), prior treatment with early docetaxel for castration- sensitive disease (yes vs no), and prior treatment with early abiraterone for castration-sensitive disease (yes vs no).  

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