NCT03617588

68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Theragnostics Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Gallium-68 THP-PSMA	Subjects will undergo a Gallium-68 THP-PSMA scan in addition to standard of care monitoring. The results of this scan may influence the patient management plan.

Timeline

• Start date: 2018-06-18
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2018-08-06
• Last updated: 2020-06-24
• Results posted: 2020-06-24

Locations

4 sites across 1 country: United Kingdom