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PROPER-ABX: F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04239742
Collaborator
ABX advanced biochemical compounds GmbH (Industry), Radboud Translational Medicine (Other)
50
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

18F-PSMA-1007 is a new radiopharmaceutical for the detection of prostate cancer with potential benefits over the registered 18F-Fluciclovine (Axumin). The main potential benefit is the higher detection rate of PSMA compared to Fluciclovin in the low PSA range. It may therefore be more sensitive in detecting local disease in case of biochemical recurrens. The investigators aim to compare the detection efficacy of 18F-PSMA-1007 to 18F-Fluciclovin in prostate cancer patients with biochemical recurrence (PSA levels 0.2-5 ng/ml).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: F18-fluciclovine PET/CT
  • Diagnostic Test: F18-PSMA-1007 PET/CT
 N/A

Detailed Description

Rationale: 18F-PSMA-1007 is a new radiopharmaceutical for detection of prostate cancer with potential benefits over 18F-Fluciclovine, such as higher detection rates at low PSA levels and small lesions, lower bone marrow uptake and higher tumour-background ratio. Therefore, 18F-PSMA-1007 PET may be more sensitive in detecting local recurrence and metastases of prostate cancer. However, Fluciclovine is a registered tracer, whereas PSMA-1007 is not registered, and therefore there is pressure to use fluciclovine instead of PSMA-1007. Therefore more comparative data are urgently needed.

Objective: Main objective is to compare detection efficacy of 18F-PSMA-1007 PET-CT to 18F-Fluciclovine, in patients with early biochemical recurrence of prostate cancer.

Study design: Comparative phase II diagnostic study Study population: 50 males >18 years, with biochemical recurrence of prostate cancer and PSA-levels between 0.2-5.0 ng/mL. About 25 of the patients must have PSA-levels between 0.2-1.0 ng/mL. Contra-indications: claustrophobia, inability to lay still for the duration of the exam. Already established local recurrence in the prostate is not a contra-indication for study participation.

Intervention: 50 patients who already were referred by their treating physician for PET/CT will receive both an 18F-PSMA-1007 PET-CT (90 minutes post injection) and an 18F-Fluciclovine PET-CT (<15 minutes post injection). Injected dose of the 18F-PSMA-1007 will be 4 MBq/kg ±10%. The injected dose of 18F-Fluciclovine is 370 MBq ±10%.

Analysis: A clinical report is made of both the 18F-PSMA-1007 PET-CT scan and 18F-Fluciclovine PET-CT scan. For further analysis in the study all data will be anonymized, and will be blindly scored by two nuclear medicine physicians. The number of PET-positive lesions (judged to be prostate cancer, of course PET positive lesions referring to different processes like inflammation will not be taken intob account, this is oart of the PET-reading process) per area are separately scored for both tracers. Lesions will be scored on a 5-point scale ranging from most probably benign to most probably malignant. Follow-up data of the patients, to determine the eventual outcome, will be extracted from their medical file. An expert panel will eventually decide which lesions are considered to be metastases using all available follow-up data.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
every individual gets two diagnostic PET CT scans within 2 weeks apart.every individual gets two diagnostic PET CT scans within 2 weeks apart.
Masking:
None (Open Label)
Masking Description:
scans will be anonymized for study outcome assessment.
Primary Purpose:
Diagnostic
Official Title:
F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer, Comparison With 18F-Fluciclovine
Actual Study Start Date :
Jan 2, 2020
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-PSMA PET/CT and 18F-Fluciclovin PET/CT

patients undergo an 18F-PSMA PET/CT scan and an 18F-Fluciclovin PET/CT scan, within a time frame of two weeks.

Diagnostic Test: F18-fluciclovine PET/CT
370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.
Other Names:
  • Axumin scan

    • Diagnostic Test: F18-PSMA-1007 PET/CT
    4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis
    Other Names:
  • PSMA scan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Detection efficacy of the two PET-tracers on a per patient level [Follow-up duration is 6 months.]

      Comparisson of number of patients with a positive scan

    2. Detection efficacy of the two PET-tracers on a per lesion level [Follow-up duration is 6 months.]

      Comparisson of number of positive lesions

    Secondary Outcome Measures

    1. Quantitative analysis [6 months]

      tumour background ratio, SUV (of tumor and normal organs)

    2. Comparing specificity [6 months]

      where the reference is consensus by the expert panel using all available information including 6 months follow up data (PSA-values; absolute and doublind time, pathology reports of suspected prostate cancer lesions, prostate-cancer targeted imaging by PET CT, MRI, CT or bone scan).

    3. Sensitivity per area, local recurrence [6 months]

      local recurrence, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    4. Sensitivity per area, locoregional lymph nodes [6 months]

      locoregional lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    5. Sensitivity per area, distant lymph nodes [6 months]

      Distant lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    6. Sensitivity per area, bone metastases [6 months]

      Bone metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data.

    7. Sensitivity per area, extraskeletal organ metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data. [6 months]

      Extraskeletal organ metastases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males ≥ 18 years

    • Histologically proven adenocarcinoma of the prostate

    • Prior local treatment with curative intent

    • Biochemical recurrence with (rising) PSA-levels of 0.2-5.0 ug/L

    • Referred by urologist for PET/CT for localization of the recurrence

    • PSA level determined <8 weeks before study participation

    • Willing to sign informed consent

    Exclusion Criteria:

    • Contra-indications for PET-CT: claustrophobia or inability to lay still for the duration of the exam.

    • Other cancer <2 years prior to biochemical recurrence of prostate cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboudumc Nijmegen Netherlands

    Sponsors and Collaborators

    • Radboud University Medical Center
    • ABX advanced biochemical compounds GmbH
    • Radboud Translational Medicine

    Investigators

    • Principal Investigator: James Nagarajah, MD, PhD, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04239742
    Other Study ID Numbers:
    • NL65593.091.18
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Jan 27, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Radboud University Medical Center
    18F-PSMA-1007
    18F-Fluciclovine
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Recurrence

    Study Results

    No Results Posted as of Jan 27, 2020