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

Phase 1
Conditions
Patients treated for non-metastasized prostate cancer with a biochemical recurrence of prostate cancer
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2018-001267-22-NL
Lead Sponsor
Radboud University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Male
Target Recruitment
50
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 <8 weeks before study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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