Prostate Cancer Clinical Trial
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
Summary
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.
Eligibility 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:
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.
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There are 4 Locations for this study
Rochester Minnesota, 55905, United States
Houston Texas, 77030, United States
Houston Texas, 77042, United States
Salt Lake City Utah, 84112, United States
Nijmegen , , Netherlands
Bern , , Switzerland
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