Using 18F-PSMA-1007 PET/CT imaging for prostate cancer assessment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III interventional study evaluates the effectiveness of 18F-PSMA-1007 PET/CT imaging in adults with prostate cancer who have specific clinical histories, such as prior radical prostatectomy or rising PSA levels after other treatments. The study aims to identify patients who may benefit from this imaging technique based on their medical history and current PSA levels. Participants will be recruited from two centers, focusing on those with high-risk features for metastatic disease or those for whom the imaging is deemed clinically beneficial by their healthcare providers.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Study coordinator: Jonathan T Abele, MD
• Email: jabele@ualberta.ca
• Phone: 780-407-6907

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.