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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04742361
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
ABX advanced biochemical compounds GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Cancer Recurrent Drug: [18F]PSMA-1007 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 8, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: [18F]PSMA-1007
single intravenous administration of [18F]PSMA-1007 for Positron Emission Tomography (PET) scan
 Drug: [18F]PSMA-1007
diagnostic radiopharmaceutical for PET scan


Outcome Measures
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Primary Outcome Measures :
  1. Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT) [ Time Frame: Within 6 months after PET/CT ]
  2. Patient-level correct detection rate of [18F]PSMA-1007 [ Time Frame: Within 6 months after PET/CT ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742361


Contacts
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Contact: Alexander Hoepping, Dr. +49 3528 4041 60 hoepping@abx.de

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Netherlands
RUMC Recruiting
Nijmegen, Netherlands
Switzerland
Inselspital, Universitätsspital Recruiting
Bern, Switzerland
Sponsors and Collaborators
ABX advanced biochemical compounds GmbH
More Information
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Responsible Party: ABX advanced biochemical compounds GmbH
ClinicalTrials.gov Identifier: NCT04742361    
Other Study ID Numbers: ABX-CT-303
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases