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.

 

 

KEYNOTE-991 / MK3475-991

Registered Title  A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)
 Purpose  This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).
 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

 

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

 Ph. 08 6318 2871

Cancer Centre Clinical Trials Unit Ph.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 Ph. 08 615 26530

Ph. 08 9346 6637

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  Ph. 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 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

 

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 Ph. (08) 6383 3204

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

 

ial 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 Ph.  (08) 615 26530

Links  Australian New Zealand Clinical Trials Registry

Acknowledgments: Australian New Zeal

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

Ph.  (08) 6465 9204

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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