UpFrontPSMA

 Prostate — Recruiting

UpFrontPSMA
Most prostate cancer cells have a molecule on their surface called prostate cancer specific membrane antigen (PSMA). PSMA can be targeted with Lutetium-177 PSMA (Lu-PSMA), a radioactive drug that kills prostate cancer cells anywhere in the body. This investigational drug is not approved for use in Australia by the Federal Government’s Therapeutic Goods Administration (TGA). It is a new form of treatment that is effective in some patients with metastatic prostate cancer. It is a radioactive substance that, after injection into a vein, attaches to prostate specific membrane antigen (PSMA). The treatment enables delivery of highly targeted radiation to cancer cells. The emitted radiation only travels about 1mm, which means it mainly causes the killing of cancer cells, while avoiding healthy cells, and seems to be well tolerated with few side effects. This is called radionuclide therapy or theranostic therapy. The purpose of this randomised controlled clinical trial is to compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own. Previous clinical trials have shown promising activity of Lu-PSMA in treatment of patients with metastatic prostate cancer. Docetaxel is a chemotherapy drug that is approved by the TGA to treat prostate cancer and has been used for many years in the treatment of metastatic prostate cancer. Since Lu-PSMA radiotherapy and docetaxel chemotherapy are both effective in treating metastatic prostate cancer, it is possible that using Lu-PSMA in addition to standard docetaxel chemotherapy at the beginning of the treatment course may improve patient outcomes when compared to treatment with docetaxel alone. A recent phase 2 clinical trial, showed the effectiveness of Lu-PSMA when used as a last treatment option and helped control disease progression. This study brings the use of Lu-PSMA forward as a first option to patients, with the hope of disease eradication and potential cure.
If you think this trial might be right for you, please ask your doctor.
If you think this trial might be right for you, please ask your doctor.
Trial Title
A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer
Cancer Type
Prostate
Trial Status
Recruiting
Protocol Number
18/047
Study Chair
Associate Professor Arun Azad (Principal Investigator) & Professor Michael Hofman (Nuclear Medicine Investigator)
Patient Population
Patients with a diagnosis of de novo high-volume mHNPC who meet all the inclusion and exclusion criteria will be eligible for participation in this study.
Recruitment Target
140 participants
Acknowledgements
Funding – Prostate Cancer Research Alliance (PCRA): An Australian Government and Movember Foundation Collaboration; Impact Award – Clinical Trial, US Department of Defence (DoD) Prostate Cancer Research Program
Detailed Information
Further Information
ClinicalTrials.gov
Participating Centres
NSW
St Vincent's Hospital - Sydney
Royal North Shore Hospital - Northern Sydney Local Health District
Liverpool Hospital - South Western Sydney Local Health District

VIC
Austin Hospital
Peter MacCallum Cancer Centre
Alfred Health - The Alfred Hospital
Monash Medical Centre

QLD
Royal Brisbane & Women's Hospital

SA
Royal Adelaide Hospital - Central Adelaide Local Health Network Inc.

WA
Sir Charles Gairdner - North Metropolitan Health Service
Fiona Stanley Hospital