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

Phase 2

Completed

Conditions: Prostate carcinoma
10038597
adenocarcinoma of the prostate

Registration Number: NL-OMON48761

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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
- PSA level determined <8 weeks before study participation

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter: detection efficacy of the different PET-tracers. Both the<br /><br>number of patients in which disease activity is objected as well as the number<br /><br>of prostate cancer lesions that are detected will be compared. Goal is to show<br /><br>superiority of 18F-PSMA-1007 compared to 18F-Fluciclovine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters:<br /><br>- Comparing specificity, where the golden standard is consensus by the expert<br /><br>panel using all available information including 6 months follow up data.<br /><br>- Analysis of the sensitivity per area: local recurrence, locoregional lymph<br /><br>nodes, distant lymph nodes, bone metastases, extraskeletal organ metastases </p><br>