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NCT06489496Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 8 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
21 Jun 2024
Start date
1 Oct 2024
Primary completion date
1 Oct 2029
Lead sponsor
Alberta Health services
NCT number
NCT06489496

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 1 Oct 2024 to the primary completion date, 1 Oct 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age less than 18 years.

Other

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

Who the study is looking for

  • Age greater than or equal to 18 years.
  • Able and willing to follow instructions and comply with the protocol.
  • Provide written informed consent prior to participation in the study.
  • 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
    • 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)

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.