18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer

NCT04733768 | Completed Phase 2

• 1 other identifier: CC-20-0281
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and diagnostic accuracy will be assessed. For diagnostic accuracy comparison will be made to a contemporary (within 10 days) conventional imaging study (bone scan and CT scan).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• Safety - immediate

  Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site

  Immediately (within 15 minutes) after 18F-PSMA-1007 injection

• Safety - post scan

  Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site

  2.5 hours after 18F-PSMA-1007 injection

• Safety - delayed

  Questionnaire (open-ended) to referring physicians to document any perceived delayed adverse events related to 18F-PSMA-1007 tracer injection

  6 months after 18F-PSMA-1007 injection

• Biodistribution

  Evaluation of whether tracer distribution is as expected based on published normal distribution and known disease

  Within 5 days of scan

• Diagnostic Accuracy

  Lesion by lesion comparison to conventional imaging (bone scan and CT scan) performed 2-10 days after the 18F-PSMA-1007 PET/CT scan. Reference standard based on lesion pathology (if available) or 1 year clinical/imaging following (using criteria published by Lawhn-Heath et al., AJR 2019;213:1-8.

  1 year after 18F-PSMA-1007 PET/CT scan

Secondary Outcomes (1)

• Clinical Efficacy

  6 months after the 18F-PSMA-1007 PET/CT scan

Study Arms (1)

18F-PSMA-1007 PET/CT scan

EXPERIMENTAL

Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan

Diagnostic Test: 18F-PSMA-1007

Interventions

18F-PSMA-1007 DIAGNOSTIC_TEST

18f-PSMA-1007 PET/CT scan

Also known as: [18F]PSMA-1007

18F-PSMA-1007 PET/CT scan

Eligibility Criteria

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

You may qualify if:

• Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) \> 0.2 µg/L
• Adult patients (≥ 18 years old) with 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
• Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score \> 7, serum PSA \> 20 µg/L, OR minimum clinical T-stage T2c.

You may not qualify if:

• Unable to obtain consent
• Weight \>225 kg (weight limitation of PET/CT scanner)
• Unable to lie flat for 30 minutes to complete the PET-CT imaging session
• Lack of intravenous access
• Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months
• History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: February 2, 2021
• Study Start: August 31, 2021
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)