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AzTrials

Prostate CancerPhase 1/2PICtureNCT04487847

18F-PSMA-1007 PET Imaging to Detect Primary Prostate Cancer

A Phase 1/2 study testing 18F-PSMA-1007 PET/CT in people with Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
18F-PSMA-1007 PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteNetherlands
Study dates
1 Sep 2020to 31 Dec 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University

    Nijmegen

Other trials in Netherlands

About this study

Official title: 18F-PSMA-1007 PET to Detect Primary Prostate Cancer: a Comparative Study With mpMRI and Correlation to Histopathology

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

Read the detailed description

Prostate cancer (PCa) is the second most common diagnosed malignancy in males worldwide, with over 1.2 million new patients diagnosed every year. Since the introduction of prostate-specific antigen (PSA) the primary diagnosis consisted of histologic confirmation by transrectal ultrasound (TRUS) systematic biopsies. However, in recent years this has changed into performing multi-parametric MR imaging (mpMRI) prior to prostate biopsy.

MpMRI has proven to be a valuable tool to avoid unnecessary prostate biopsies and prevent over-treatment of low-grade PCa, while maintaining equal or higher detection rates of high-grade PCa. Prostate MRI is evaluated using the Prostate Imaging-Reporting and Data System (PIRADS). Lesions are given a category score, from 1 (high-grade PCa is unlikely to be present) to 5 (presence of high-grade PCa is highly likely). A PIRADS 3 is an equivocal scan. Nonetheless, mpMRI has room for improvement as its specificity for high-grade tumors is only 73% and local staging is limited with mpMRI. Also, the mpMRI is frequently unclear as 4-39% of detected lesions are classified as PIRADS 3.

Prostate-specific membrane antigen receptor (PSMA) is highly overexpressed by 95% of the prostate cancer cells and seem to positively correlate to aggressiveness of the tumor. PSMA-positron emission tomography (PET) uses this feature by visualizing PSMA expressing prostate tumors. Currently, the PSMA-PET is generally used to detect recurrences or metastases. However, there is an increasing interest for PSMA-PET scans in patients with a primary diagnosis of PCa for staging purposes. Yet, there is no published data on the role of PSMA-PET on PCa prior to biopsy in comparison to the detection rate of mpMRI and histopathology.

This study aims to investigate the added value of a 18F-PSMA-PET to mpMRI in the detection of local prostate cancer lesions.

75 patients with the suspicion on prostate cancer (e.g. elevated PSA and/or abnormal digital rectal exam) will receive a 18F-PSMA-1007 PET following mpMRI. 25 patients with PIRADS 1-2 (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with PIRADS 4-5 (highly suspicious for malignancy) will be included in this study.

If either the mpMRI or 18F-PSMA-1007 PET shows a potential malignant lesion, a (target) biopsy will be performed.

Conditions
Prostate Cancer
Being tested
18F-PSMA-1007 PET/CT
Keywords
Prostate cancer, Staging, PET imaging, PSMA-1007, mpMRI
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-PSMA-1007 PET/CTDiagnostic test

    18F-PSMA-1007 PET/CT

Study groups in NCT04487847
Study groupRoleWhat they receive
PIRADS 1-2Experimental25 patients with PIRADS 1-2 (probably benign) on mpMRI
Receives: Diagnostic Test: 18F-PSMA-1007 PET/CT
PIRADS 3Experimental25 patients with PIRADS 3 (equivocal scan) on mpMRI
Receives: Diagnostic Test: 18F-PSMA-1007 PET/CT
PIRADS 4-5Experimental25 patients with PIRADS 4-5 (probably malignant) on mpMRI
Receives: Diagnostic Test: 18F-PSMA-1007 PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start1 Sep 2020
  3. Primary completion28 Feb 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Explorative study of 18F-PSMA-1007 PET to detect prostate cancer
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04487847
Sponsor's protocol ID
NL73559.091.20
Acronym
PICture
Status last verified
Feb 2023
First submitted
22 Jul 2020
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28196723

  • 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.

    PubMed 26361169

  • 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.

    PubMed 26215604

  • 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.

    PubMed 30477981

  • 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.

    PubMed 32999466

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 18F-PSMA-1007 PET/CT in people with Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare mpMRI,18F-PSMA-1007 PET and histopathology. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04487847, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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