A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients With High Risk Primary Prostate Cancer or Biochemical Recurrence After Radical Treatment (PRONOUNCED Study)
Phase: PHASE2
Conditions: Prostate Cancer
Sponsor: Theragnostics Ltd

Protocol version: 2.0 (29 October 2018) Theragnostics Ltd Protocol number: THERAG0001 
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Synopsis 
Study Title 
A Phase II, Open-label Study to Assess Safety and Clinical Utility of 
68Ga-THP-PSMA PET/CT in Patients with High-risk Primary Prostate 
Cancer or Biochemical Recurrence after Radical treatment 
Short Title 
68Ga-THP-PSMA PET/CT imaging in high-risk primary prostate cancer or 
biochemical recurrence of prostate cancer. 
Study Design 
This is a Phase II, open-label study to evaluate the safety and clinical utility of 
gallium 68-trishydroxypyridinone-prostate-specific membrane antigen 
(68Ga-THP-PSMA) Positron Emission Tomography (PET)/Computed 
Tomography (CT) in patients with high-risk primary prostate cancer (PCa) or 
with biochemical recurrence (BCR) of PCa. 
Study Patients 
 Group A: Patients who have been diagnosed with high-risk primary PCa and 
indicated for primary radical curative therapy; 
 Group B: Patients with BCR being considered for radical salvage treatment 
(with curative intent), having had primary radical curative prostatectomy 
performed at least 3 months before enrolment; 
 Group C: Patients with BCR being considered for radical salvage treatment 
(with curative intent), having had primary radical curative radiotherapy (but 
no surgery) performed at least 3 months before enrolment. 
Planned Sample 
Size 
Recruitment of approximately 60 patients. 
Planned Study 
Period 
Patient recruitment is planned to start: June 2018 
Last patient in: End December 2018 
 
Objectives 
Endpoints 
Primary 
Evaluation of 68Ga-PSMA PET impact 
on the management of patients with 
PCa cancer in the setting of: 
1. BCR in patients treated with 
radical prostatectomy 
2. BCR in patients treated with 
radiotherapy 
3. newly diagnosed high-risk PCa
Change in-patient management as a 
result of 68Ga-PSMA PET 
documented after scan, compared with 
pre-scan management plan 
Secondary 
Evaluation of safety of 68Ga-PSMA in 
patients with PCa 
Adverse events: Clinically significant 
changes in heart rate, blood pressure, 
electrocardiogram, urinalysis and 
baseline serum haematology and 
biochemistry profile 
Tertiary 
(exploratory) 
Evaluation of technical feasibility of 
68Ga-PSMA in patients with PCa 
Technical success/failure of study, 
artefacts, pitfalls in interpretation 
Correlation of PSMA on imaging and 
PSMA within tumour 
Correlation of degree of uptake on 
PET/CT with histopathological 
staining of PSMA as per standard of 
care where histology is available