F18-PSMA-1007 PET for early biochemical recurrence of prostate cancer.

F18-PSMA-1007 PET for early biochemical recurrence of prostate cancer, comparison with 18F-Fluciclovine.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001267-22-NL

Enrollment

Registered

2018-06-11

Start date

2019-10-10

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients treated for non-metastasized prostate cancer with a biochemical recurrence of prostate cancer

Interventions

Product Name: [18F]F-PSMA-1007 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: [18F]F-PSMA-1007 Other descriptive name: [18F]F-PSMA-1007 Concentration unit: MBq/kg megabecque

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Males = 18 years - Histologically proven adenocarcinoma of the prostate - Prior local treatment with curative intent - Biochemical recurrence with PSA-levels of 0.2-5.0 ug/L - PSA level determined =65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: A patient will be excluded from participation in the trial if one or more of the following criteria are met: - 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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary objectives: 1. Comparing specificity, where the golden standard is defined by an expert panel using data of both PET-CT’s and 6 months follow up data. 2. Analysis of the sensitivity per area (local recurrence, locoregional lymph nodes, distant lymph nodes, bone metastases, other location) 3. Quantitative analyses: SUV measurements, tumor-background ratio’s. ;Primary end point(s): Main study parameter: detection efficacy of the different PET-tracers. Both the number of patients in which disease activity is objected as well as the number of prostate cancer lesions that are detected will be compared. Goal is to show superiority of 18F-PSMA-1007 compared to 18F-Fluciclovine. ;Timepoint(s) of evaluation of this end point: LVLS.;Main 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 with low PSA-levels (0.2-5.0 ug/L).	—

Measure

Time frame

Secondary Objective: Secondary objectives: 1. Comparing specificity, where the golden standard is defined by an expert panel using data of both PET-CT’s and 6 months follow up data. 2. Analysis of the sensitivity per area (local recurrence, locoregional lymph nodes, distant lymph nodes, bone metastases, other location) 3. Quantitative analyses: SUV measurements, tumor-background ratio’s. ;Primary end point(s): Main study parameter: detection efficacy of the different PET-tracers. Both the number of patients in which disease activity is objected as well as the number of prostate cancer lesions that are detected will be compared. Goal is to show superiority of 18F-PSMA-1007 compared to 18F-Fluciclovine. ;Timepoint(s) of evaluation of this end point: LVLS.;Main 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 with low PSA-levels (0.2-5.0 ug/L).

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Secondary

Measure	Time frame
Secondary end point(s): Secondary parameters: 1. Comparing specificity, where the golden standard is defined by an expert panel using data of both PET-CT’s and 6 months follow up data. 2. Analysis of the sensitivity per area (local recurrence, locoregional lymph nodes, distant lymph nodes, bone metastases, other location) 3. Quantitative analyses: SUV measurements, tumor-background ratio’s. ;Timepoint(s) of evaluation of this end point: LVLS.	—

Measure

Time frame

Secondary end point(s): Secondary parameters: 1. Comparing specificity, where the golden standard is defined by an expert panel using data of both PET-CT’s and 6 months follow up data. 2. Analysis of the sensitivity per area (local recurrence, locoregional lymph nodes, distant lymph nodes, bone metastases, other location) 3. Quantitative analyses: SUV measurements, tumor-background ratio’s. ;Timepoint(s) of evaluation of this end point: LVLS.

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Countries

Netherlands

Contacts

Public ContactDr. M.J.R. Janssen

Radboud University Medical Center

Marcel.Janssen@radboudumc.nl00310243615306

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026