TheranosticTrials.org

Clinical Trial · NCT06489496

Prostate Cancer 18F-PSMA-1007 PET/CT Access Trial

Overview

Primary objective: • To determine if 18F-PSMA-1007 PET/CT imaging is effective at diagnosing prostate cancers and/or metastases compared to conventional imaging \[including CT, MRI, 99mTc-MDP Bone Scans as available\]. Secondary Objective: * To determine safety by evaluating for adverse events * To determine which conventional imaging is being performed when 18F-PSMA-1007 PET/CT imaging is available

Sponsor

Alberta Health Services

Contacts

Denise Chan (CONTACT)

denise.chan@albertahealthservices.ca

403-944-1252

ClinicalTrials.gov

NCT06489496

Drug / Compound

PSMA-1007

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
  • One of the following:
  • a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 µg/L
  • a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of \< 9 months
  • a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or other similar therapy. High-risk features include a Gleason score ≥ 8, serum PSA \> 20 µg/L, OR minimum clinical T-stage T3a
  • Able and willing to follow instructions and comply with the protocol.

Exclusion

  • Lack of intravenous access
  • Unable to obtain consent
  • Unable to lie flat for 30 minutes to compete PET/CT imaging.