68Ga-THP-PSMA PET/CT imaging in primary and recurring prostate cancer

• Research type

  Research Study

• Full 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

• IRAS ID

  241124

• Contact name

  Asim Afaq

• Sponsor organisation

  Theragnostics Limited

• Eudract number

  2017-005010-59

• Duration of Study in the UK

  0 years, 8 months, 30 days

• Research summary

  The primary purpose of this study is the evaluation of a Positron Emission Tomography (PET) radiotracer called 68Ga-THP-PSMA, when combined with PET/CT (computed tomography scans) and the impact on the management of patients with High Risk Primary Prostate Cancer or Biochemical Recurrence (BCR) After Radical Treatment.

  This study 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.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  18/LO/0370

• Date of REC Opinion

  13 Apr 2018

• REC opinion

  Further Information Favourable Opinion