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Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.

NCT04644822 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-07

No results posted yet for this study

Summary

This is a prospective, Phase 3 non-randomized, open label, multi-centre clinical trial to assess the safety and efficacy of \[18F\]PSMA-1007 Injection (investigational product or IP) in evaluating men with suspected persistent or recurrent disease (i.e., with biochemical failure), but with negative or equivocal conventional re-staging imaging (bone scan \[BS\] and computed tomography \[CT\] of abdomen and pelvis).

Conditions

  • Prostate Cancer Recurrent
  • Recurrent Prostate Cancer

Interventions

DIAGNOSTIC_TEST

[18F] PSMA-1007 Injection

a novel \[18F\] PSMA radiotracer that is highly selective for PSMA.

Sponsors & Collaborators

  • McDougall Scientific Ltd.

    collaborator UNKNOWN

  • Centre for Probe Development and Commercialization

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2024-01-08
Completion
2024-01-08

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04644822 on ClinicalTrials.gov