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

Overview

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age:  ≥ 18 years.
  • 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 than 18 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.

Eligibility last updated 8/27/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Val Lowe, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Kera Delaney CCRP

Delaney.Kera@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20520774

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