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

NCT06489496 | Not Yet Recruiting DMC

• 1 other identifier: AlbertaHS
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of 18F-PSMA-1007 PET/CT imaging to CT/MRI/Bone scans in identifying prostate cancer and/or metastases

  calculate sensitivity and specificity 18F-PSMA 1007 PET/CT compared to CT, MRI and bone scans using pathology and follow up as gold standard.

  5 year study, approximately 200 patients/ year.

Secondary Outcomes (1)

• To determine safety by evaluating for adverse events

  5 year study, approximately 200 patients/ year.

Interventions

18F-1007 PSMA PSMA PET/CT DIAGNOSTIC_TEST

Each patient will receive an IV injection 18F-PSMA-1007 PET/CT. PET/CT Imaging will be conducted beginning 90-120 minutes after an injection of 4 MBq/kg (max 400 MBq +/- 15%) 18F-PSMA-1007 in patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with history of prostate cancer for staging or clinically suspected recurrent prostate cancer

You may qualify if:

• 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)

You may not qualify if:

• Unable to obtain consent
• Age less than 18 years.
• Unable to lie flat for 30 minutes to compete PET/CT imaging.
• Lack of intravenous access

Sponsors & Collaborators

• Alberta Health services: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Denise Chan

CONTACT

403-944-1252; denise.chan@albertahealthservices.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 8, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share