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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04733768
Recruitment Status : Active, not recruiting
First Posted : February 2, 2021
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: 18F-PSMA-1007 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-PSMA-1007 PET/CT Imaging in Patients With Biochemically Recurrent or High-risk Prostate Cancer
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 18F-PSMA-1007 PET/CT scan
Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan
Diagnostic Test: 18F-PSMA-1007
18f-PSMA-1007 PET/CT scan
Other Name: [18F]PSMA-1007




Primary Outcome Measures :
  1. Safety - immediate [ Time Frame: Immediately (within 15 minutes) after 18F-PSMA-1007 injection ]
    Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site

  2. Safety - post scan [ Time Frame: 2.5 hours after 18F-PSMA-1007 injection ]
    Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site

  3. Safety - delayed [ Time Frame: 6 months after 18F-PSMA-1007 injection ]
    Questionnaire (open-ended) to referring physicians to document any perceived delayed adverse events related to 18F-PSMA-1007 tracer injection

  4. Biodistribution [ Time Frame: Within 5 days of scan ]
    Evaluation of whether tracer distribution is as expected based on published normal distribution and known disease

  5. Diagnostic Accuracy [ Time Frame: 1 year after 18F-PSMA-1007 PET/CT scan ]
    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.


Secondary Outcome Measures :
  1. Clinical Efficacy [ Time Frame: 6 months after the 18F-PSMA-1007 PET/CT scan ]
    Questionnaire completed by referring physicians evaluating the perceived clinical effect of the 18F-PSMA-1007 PET/CT on patient management



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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
  3. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04733768


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04733768    
Other Study ID Numbers: CC-20-0281
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases