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

ABX Advanced Biochemical Compounds

Status and phase: Active, not recruiting; Phase 3

Conditions: Prostate Cancer Recurrent; Prostate Cancer

Treatments: Drug: [18F]PSMA-1007

Study type: Interventional

Funder types: Industry

Identifiers

NCT04742361

ABX-CT-303

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

[18F]PSMA-1007

Experimental group

Description:

single intravenous administration of \[18F\]PSMA-1007 for Positron Emission Tomography (PET) scan

Treatment:

Drug: [18F]PSMA-1007