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Prostate

he 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.

Galahad

Registered Title	A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Purpose	"The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies."
Lay Summary	N/A
WA Trial Sites	Cancer Centre Clinical Trials Unit Phone 08 615 26530
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 Phone 08 615 26530 08 9346 6000
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

KEYNOTE 641

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. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate 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 Phone 08 615 26530
Links	US National Library of Medicine

Acknowledgements: 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 polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)"
Lay Summary	N/A
WA Trial Sites	Cancer Centre Clinical Trials Unit Phone 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
Links	Australian New Zealand Clinical Trials Registry

Acknowledgments: Australian New Zealand Clinical Trials Registry

CORE (TROG 16.03)

Registered Title	A randomised trial of COnventional care versus Radioablation (stereotactic body radiotherapy) for Extracranial oligometastases.
Purpose	The CORE study aims to understand whether there is a benefit in adding a type of radiotherapy called Stereotactic Body Radiation Therapy (SBRT) to the standard treatment in people with breast, prostate, or non-small cell lung cancer (NSCLC) which has spread to 3 or less areas of the body (known as oligometastatic disease).
Lay Summary	Assessing the benefit of targeted radiotherapy added to standard of care in the management of isolated metastases outside the brain.
WA Trial Sites	SCGH - Radiation Oncology (08) 6383 3204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

TheraP

Registered Title	A randomised phase 2 trial of 177Lu-PSMA617 theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer
Purpose	The primary purpose of this trial is to evaluate the efficacy and safety of a new radionuclide therapy (177Lu-PSMA617) for advanced prostate cancer, in comparison to the standard care, cabazitaxel. 177Lu-PSMA617 is a radioactive molecule that specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues.
Lay Summary	Who is it for? You may be eligible to participate in this trial if you have been diagnosed with metastatic castration resistant prostate cancer for which you have previously received docetaxel. Study details All patients enrolled into this trial will be randomly allocated (by chance) to receive either 177Lu-PSMA617 or the standard care cabazitaxel chemotherapy. Patients in the 177Lu-PSMA617 arm will receive up to six six-weekly doses of 177Lu-PSMA617. Patients in the cabazitaxel arm will receive up to ten three-weekly doses of cabazitaxel. Treatment in both arms will continue until your cancer progresses, you have unmanageable side effects or until the maximum number of treatments has been reached. All patients will complete scans and questionnaires as part of this trial, up to every 3 weeks, to assess the impact of the treatment on your cancer, on your pain levels and your quality of life. It is hoped that this trial will provide further information on the risks and benefits of 177Lu-PSMA617 treatment compared with cabazitaxel in men with advanced prostate cancer.
WA Trial Sites	Cancer Centre Clinical Trials Unit (08) 615 26530
Links	Australian New Zealand Clinical Trials Registry

Acknowledgments: Australian New Zealand Clinical Trials Registry

TRITON2

Registered Title	TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in 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.
Lay Summary	N/A
WA Trial Sites	St John of God - Subiaco (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

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	St John of God - Subiaco (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

PROfound - Active not recruiting

Registered Title	A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparzaâ„¢) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)
Purpose	The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.
Lay Summary	N/A
WA Trial Sites	SCGH - Medical Oncology (08) 6383 3000
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

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