Prostate
The following list provides a brief description of prostate cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.
Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.
Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.
PROPELLER
| Registered Title | Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study |
| Purpose | The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer. |
| Lay Summary | N/A |
| WA Trial Sites |  |
| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
CUPID
| Registered Title | A Phase I, Single Centre, Open-label Study of TLX592 to Assess the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry in Patients Diagnosed With Prostate Cancer |
| Purpose | This is a Phase 1 trial of TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592). TLX592 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours, therefore this study has been designed to assess the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of 64Cu-TLX592. |
| Lay Summary | N/A |
| WA Trial Sites | Ph. 08 6318 2871 |
| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
AMPLITUDE
| Registered Title | A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) |
| Purpose | The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival(rPFS) |
| Lay Summary | |
| WA Trial Sites |  Oncology Ph. 08 615 26530
|
| Links | US National Library of Medicine |
Ph. (08) 6465 9204Acknowledgements: US National Library of Medicine
Prevalence 64091742PCR0002
| Registered Title | Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer |
| Purpose | The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies. |
| Lay Summary | N/A |
| WA Trial Sites | Oncology Ph. 08 615 26530 |
| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
CheckMate 914
| Registered Title | A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse |
| Purpose | The purpose of this study is to determine whether the combination of nivolumab and ipilimumab is safe and effective for delaying or preventing recurrence of cancer in patients who have experienced the partial or entire removal of a kidney. |
| Lay Summary | N/A |
| WA Trial Sites |  |
| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
DASL-HiCaP (ANZUP1801)
| Registered Title | DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer |
| Purpose | The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence. |
| Lay Summary | N/A |
| WA Trial Sites |
|
| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
MAGNITUDE
| Registered Title | A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer |
| Purpose | "The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate and prednisone (AA-P) compared to AA-P plus placebo." |
| Lay Summary | N/A |
| WA Trial Sites | Cancer Centre Clinical Trials Unit Ph. 08 615 26530
|
| Links | US National Library of Medicine |
KEYNOTE 641
Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate
Acknowledgements: US National Library of Medicine
Registered Title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)
Purpose
The purpose of this study is to assess the efficacy and safety of the combination of
pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic
castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC,
are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are
two primary study hypotheses.
enzalutamide with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus
Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1
(RECIST 1.1) as assessed by blinded independent central review."
Lay Summary
N/A
WA Trial Sites
Cancer Centre Clinical Trials Unit Ph. 08 615 26530
Links
US National Library of Medicine
KEYLYNK-010
| Registered Title | A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010) |
| Purpose |
The purpose of this study is to assess the efficacy and safety of the combination of the 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group |
| Lay Summary | N/A |
| WA Trial Sites | Cancer Centre Clinical Trials Unit Ph. 08 615 26530 |
| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
ENHA01
| Registered Title | Exploring the role of androgen receptor blockade in increasing the expression of prostate specific membrane antigen (PSMA) and enhancing 68Ga-PSMA-11-PET/CT imaging in patients with metastatic prostate cancer |
| Purpose | The purpose of this study is to determine the effect of androgen deprivation therapy, a treatment commonly prescribed in prostate cancer patients, on the effectiveness of medical imaging techniques. |
| Lay Summary | N/A |
| WA Trial Sites |  Ph. 08 6318 2871 |
| Links | Australian New Zealand Clinical Trials Registry |
Acknowledgments: Australian New Zealand Clinical Trials Registry
TRITON3
| Registered Title |
TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency |
|
Purpose |
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel. |
|
Lay Summary |
N/A |
|
WA Trial Sites |
|
|
Links |
Ph. Acknowledgements: US National Library of Medicine
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