NCT04487847

Brief Summary

To study the added value of 18F-PSMA-1007 PET to mpMRI in the detection of local prostate cancer lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 16, 2025

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

July 22, 2020

Last Update Submit

January 14, 2025

Conditions

Prostate Cancer

Keywords

Prostate cancerStagingPET imagingPSMA-1007mpMRI

Outcome Measures

Primary Outcomes (1)

  • Compare mpMRI,18F-PSMA-1007 PET and histopathology.

    Within each of the three PIRADS groups (1-2, 3, 4-5) the fraction of patients in which the diagnosis based on mpMRI and 18F-PSMA-1007 PET differ is evaluated.

    30 days

Study Arms (3)

PIRADS 1-2

EXPERIMENTAL

25 patients with PIRADS 1-2 (probably benign) on mpMRI

Diagnostic Test: 18F-PSMA-1007 PET/CT

PIRADS 3

EXPERIMENTAL

25 patients with PIRADS 3 (equivocal scan) on mpMRI

Diagnostic Test: 18F-PSMA-1007 PET/CT

PIRADS 4-5

EXPERIMENTAL

25 patients with PIRADS 4-5 (probably malignant) on mpMRI

Diagnostic Test: 18F-PSMA-1007 PET/CT

Interventions

18F-PSMA-1007 PET/CTDIAGNOSTIC_TEST

18F-PSMA-1007 PET/CT

PIRADS 1-2PIRADS 3PIRADS 4-5

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination)
  • Males ≥ 18 years
  • ECOG 0-1
  • Signed informed consent

You may not qualify if:

  • Prostate biopsy in the last 6 months
  • History of prostate cancer
  • Second active malignancy
  • Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip replacement surgery)
  • Any medical condition that in the opinion of the investigator will affect patients' clinical status when participating in this trial.
  • Contra-indications for mpMRI or PET: claustrophobia or inability to lay still for the duration of the exam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University

Nijmegen, Netherlands

Location

Related Publications (5)

  • Woo S, Suh CH, Kim SY, Cho JY, Kim SH. Diagnostic Performance of Prostate Imaging Reporting and Data System Version 2 for Detection of Prostate Cancer: A Systematic Review and Diagnostic Meta-analysis. Eur Urol. 2017 Aug;72(2):177-188. doi: 10.1016/j.eururo.2017.01.042. Epub 2017 Feb 11.

    PMID: 28196723BACKGROUND

  • Barentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8. No abstract available.

    PMID: 26361169RESULT

  • de Rooij M, Hamoen EH, Witjes JA, Barentsz JO, Rovers MM. Accuracy of Magnetic Resonance Imaging for Local Staging of Prostate Cancer: A Diagnostic Meta-analysis. Eur Urol. 2016 Aug;70(2):233-45. doi: 10.1016/j.eururo.2015.07.029. Epub 2015 Jul 26.

    PMID: 26215604RESULT

  • van der Leest M, Cornel E, Israel B, Hendriks R, Padhani AR, Hoogenboom M, Zamecnik P, Bakker D, Setiasti AY, Veltman J, van den Hout H, van der Lelij H, van Oort I, Klaver S, Debruyne F, Sedelaar M, Hannink G, Rovers M, Hulsbergen-van de Kaa C, Barentsz JO. Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naive Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study. Eur Urol. 2019 Apr;75(4):570-578. doi: 10.1016/j.eururo.2018.11.023. Epub 2018 Nov 23.

    PMID: 30477981RESULT

  • Prive BM, Israel B, Schilham MGM, Muselaers CHJ, Zamecnik P, Mulders PFA, Witjes JA, Sedelaar M, Mehra N, Verzijlbergen F, Janssen MJR, Gotthardt M, Barentsz JO, van Oort IM, Nagarajah J. Evaluating F-18-PSMA-1007-PET in primary prostate cancer and comparing it to multi-parametric MRI and histopathology. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):423-430. doi: 10.1038/s41391-020-00292-2. Epub 2020 Sep 30.

    PMID: 32999466DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Explorative study of 18F-PSMA-1007 PET to detect prostate cancer
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 27, 2020

Study Start

September 1, 2020

Primary Completion

February 28, 2023

Study Completion

December 31, 2023

Last Updated

January 16, 2025

Record last verified: 2023-02

Locations

NL(1)