UpFrontPSMA Trial

Trial Title:

A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer


Trial Acronym:

UpFrontPSMA

Protocol Number:

18/047

Trial Design:

Open label, randomised, stratified, 2-Arm, multi-centre, phase 2


Sponsor:

Peter MacCallum Cancer Centre

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 

Collaborators: 
 

Movember Foundation
Prostate Cancer Research Alliance
United States Department of Defense
Advanced Accelerator Applications
Australian Nuclear Science and Technology Organisation (ANSTO)
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Australasian Radiopharmaceutical Trials network (ARTnet)
Centre for Biostatistics and Clinical Trials (BaCT)

Coordinating Principal Investigator: 

A/Prof. Arun Azad, Peter Maccallum Cancer Centre

Coordinating Nuclear Medicine Investigator:

Prof. Michael Hofman, Peter MacCallum Cancer Centre

ANZ Coordinating Centre:

Centre for Biostatistics and Clinical Trials (BaCT)

Trial Coordinator:

Annette VanDerHeyden

Trial Email:

Annette.VanDerHeyden@petermac.org


Recruitment Aim: 
 

140 participants

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. 

Intervention:

Arm A (Experimental): 7.4 GBq (± 10%) 177Lu-PSMA every 6 weeks x 2 cycles. Docetaxel 75 mg/m2 commencing 6 weeks later, every 3 weeks x 6 cycles

Arm B (Control): Docetaxel 75 mg/m2 every 3 weeks x 6 cycles

Primary Objective:

To compare the undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy in male patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC) treated with sequential 177Lu-PSMA and docetaxel versus those treated with docetaxel alone  

Secondary Objectives:

  1. To evaluate the safety of 177Lu-PSMA followed by docetaxel compared to docetaxel alone
  2. To compare time to development of castration resistance between treatment Arms
  3. To compare PSA progression free survival (PSA-PFS) between treatment Arms
  4. To compare the radiographic progression-free survival (rPFS) between treatment Arms
  5. To compare radiographic response  rates between treatment Arms
  6. To compare early prostate-specific membrane antigen (PSMA) PET response between treatment Arms
  7. To describe and compare health-related quality of life (QoL) and pain within 12 months of treatment commencement between treatment Arms
  8. To compare overall survival (OS) between treatment Arms

Status:

Active and recruiting

Sites Recruiting:


VIC
Peter MacCallum Cancer Centre 
Austin Hospital 

NSW
St Vincent's Hospital Sydney 

QLD
Royal Brisbane and Women's Hospital 

Further information:

Click here
 
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