Clinical trial NCT04742361: Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
Official title: Phase III Study of [18F]PSMA-1007 Positron Emission Tomography for the Detection of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Prostate Cancer Recurrent
Lead sponsor: ABX advanced biochemical compounds GmbH
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 136
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Primary outcomes:
measure: Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)
timeFrame: Within 6 months after PET/CT
measure: Patient-level correct detection rate of [18F]PSMA-1007
timeFrame: Within 6 months after PET/CT
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Excel Diagnostics and Nuclear Oncology Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Nijmegen
country: Netherlands
facility: RUMC
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital
Study officials:
References: