For Healthcare Professionals

Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
  2. Suspicion of recurrence or persistence

  1. after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
  2. 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)
  3. 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.
  4. Life expectancy of 6 months or more as judged by the investigator
  5. Willing and able to undergo all study procedures
  6. Informed consent in writing

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Age: less than18 years
  2. Contraindications to any of the ingredients of [18F]PSMA-1007
  3. Close affiliation with the investigational site
  4. 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
  5. Having been previously enrolled in this clinical trial
  6. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
  7. Being clinically unstable or requiring emergency treatment
  8. Patients who are unwilling to consider a biopsy if clinically recommended
  9. Patients who are unable to undergo a PET/CT scan
  10. Patients for whom systemic therapy is the most likely course regardless of PET findings.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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