Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
About the study
This study evaluates the diagnostic performance and safety of \[18F\]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
- Suspicion of recurrence or persistence
- after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
- after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
- For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
- Life expectancy of 6 months or more as judged by the investigator
- Willing and able to undergo all study procedures
- Informed consent in writing
EXCLUSION CRITERIA
Exclusion Criteria:
- Age: less than18 years
- Contraindications to any of the ingredients of [18F]PSMA-1007
- Close affiliation with the investigational site
- At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
- Having been previously enrolled in this clinical trial
- Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- Being clinically unstable or requiring emergency treatment
- Patients who are unwilling to consider a biopsy if clinically recommended
- Patients who are unable to undergo a PET/CT scan
- Patients for whom systemic therapy is the most likely course regardless of PET findings.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Prostate Cancer,Prostate Cancer Recurrent
Age (in years)
18+
Phase
PHASE3
Participants needed
136
Est. Completion Date
Oct 31, 2024
Treatment type
INTERVENTIONAL
Sponsor
ABX advanced biochemical compounds GmbH
ClinicalTrials.gov identifier
NCT04742361
Study number
ABX-CT-303
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