Status:

RECRUITING

18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028

Lead Sponsor:

University of Alberta

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE3

Brief Summary

A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 1. Adults patients (≥18 years old) with a history of radical prostatectomy for treatme...

Eligibility Criteria

Inclusion Criteria:

  1. Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
  2. Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
  3. Adult participants with 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 ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
  4. Adult 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)

Exclusion Criteria:

  1. Unable to obtain consent
  2. Weight > 225 kg (weight limit of PET/CT scanners)
  3. Unable to lie flat for 30 minutes to complete the PET/CT imaging session
  4. Lack of intravenous access
  5. History of allergic reaction to 18F-PSMA-1007
  6. Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
  7. Less than 18 years old

NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation

Key Trial Info

Start Date :

July 25 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2029

Estimated Enrollment :

2800 Patients enrolled

Trial Details

Trial ID

NCT05520255

Start Date

July 25 2023

End Date

December 1 2029

Last Update

September 23 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Alberta

Edmonton, Alberta, Canada, T6G 2R3