proPSMA Trial

Trial Title:

A prospective randomised multi-centre study of the impact of Ga-68 PSMA-PET/CT
imaging for staging high risk prostate cancer prior to curative-intent surgery or radiotherapy

Trial Acronym:

proPSMA

Protocol Number:

HREC/16/PMCC/130

 

Trial Design:

Prospective, open label, randomised phase III (imaging study)

Sponsor: Peter MacCallum Cancer Centre

Funding:

Prostate Cancer Foundation of Australia (PCFA) through a Clinical Trials Grant from Movember

Collaborators:   ARTnet, Centre for Health Economics Research and Evaluation (University of Technology Sydney), USANZ, ANZUP Cancer Trials Group and TROG  

ANZ Study Chairs:

Prof Michael Hofman

ANZ Coordinating Centre:

Centre for Biostatistics and Clinical Trials (BaCT)

Trial Coordinator:

Ania Matera

 

Trial Email:

ania.matera@petermac.org


Recruitment Aim: 
 

300 participants

Patient Population:

1. Untreated biopsy-proven prostate cancer being considered for curative intent treatment with surgery or radiotherapy
2. High risk, defined by: PSA≥20ng/mL or Gleason grade group 3-5 or clinical stage≥T3

Intervention:

Arm A: Experimental arm. PSMA-PET/CT imaging, 150 patients
Arm B: Control arm. Conventional imaging (CT + bone scan), 150 patients

Primary Objective:

1. To compare the diagnostic accuracy of PSMA-PET/CT to that of conventional imaging (CI) for detecting pelvic nodal or distant metastatic disease.

Secondary Objective:

1. To compare the first-line management impact of PSMA-PET/CT to that of CI
2. To compare the number of equivocal study results using PSMA-PET/CT to the number using CI
3. To assess incremental accuracy of PSMA-PET/CT or CI as a second-line imaging modality by their ability to detect additional metastases in a subset of patients who cross-over and have both tests
4. To assess the incremental management impact of PSMA-PET/CT or CI as a second-line imaging modality in the subset of patients who cross-over and have both tests
5. To evaluate the prognostic value of PSMA-PET/CT with regards to disease-free status (3 years from accrual of the last patient)
6. To compare the cost of each imaging staging strategy
7. To compare the diagnostic accuracy of PSMA-PET/CT to that of conventional imaging (CI) for detecting pelvic nodal disease specifically, and for detecting distant metastases specifically
8. To compare patient radiation exposure between imaging strategies
9. To assess inter-reporter agreement of PSMA-PET/CT by comparing blinded independent central imaging laboratory interpretations to on-site clinical care interpretations
10. To report the acute adverse events for PSMA-PET/CT

Exploratory objectives:
1. Investigate the diagnostic accuracy of whole body MRI compared to PSMA PET/CT in a non-randomised exploratory endpoint

Status:

Closed to recruitment 

Sites Recruiting:

Victoria
Peter MacCallum Cancer Centre
Austin Health - Austin Hospital
Monash Medical Centre - Clayton campus
St Vincent's Hospital (Melbourne) Ltd

NSW
Calvary Mater Newcastle
Royal North Shore Hospital

Queensland 
Royal Brisbane & Women's Hospital
Princess Alexandra Hospital

Western Australia
Sir Charles Gairdner Hospital 

South Australia 
The Royal Adelaide Hospital
South Australian Health and Medical Research Institute

Further information:

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