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AzTrials

Prostate CancerNCT06494696

68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

An observational study of Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 40 to 85 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Ga-68 PSMA PET/MRI
How many people
71 participants
Where
1 siteTaiwan
Study dates
1 Jul 2024to 31 May 2027
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 40 to 85 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.

Who may be able to join

  • Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.
  • Males aged between 40 and 85 years with a life expectancy greater than two years.
  • Naïve to prostate biopsy in the past.
  • Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
  • Willing to sign the informed consent.

Who cannot join

  • Unable to tolerate the PET/MRI scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable, or having MRI unsafe metallic implants or devices.
  • With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
  • High risk to conduct examination after evaluations of PI
  • Patient had previous malignancy history

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jing-Ren Tseng, MD contact

+886-975361314

drTsengJR@gmail.com

Taiwan1 site, 1 recruiting

  • Chang Gung Memorial Hospital ,Linkou

    Taoyuan City, 333

    Jing-Ren Tseng, MD, 09753-61314, b9105019@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Utilizing 68Ga-PSMA PET/MRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are:

  1. Does PSMA PET/MRI have better PPV and NPV than mpMRI to diagnose prostate cancer?
  2. Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy?
Read more

Participants will:

  1. Undergo a Ga-68 PSMA PET/MRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan.
  2. Between the follow-up period, visit the clinic once every 6 months for checkups and blood tests.
Conditions
Prostate Cancer
Being tested
Ga-68 PSMA PET/MRI
Keywords
Ga-68 PSMA PET/MRI, PI-RADS, Biopsy naive
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Ga-68 PSMA PET/MRIDiagnostic test

    The participant will undergo a Ga-68 PSMA PET/MRI scan, and then be followed up for 2 years to see if prostate cancer is diagnosed.

Study groups in NCT06494696
Study groupRoleWhat they receive
ExperimentalNot described
Receives: Diagnostic Test: Ga-68 PSMA PET/MRI

What is being measured

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

  1. PPV of concordant PET/MRI lesion plus PI-RADS score 4~5

    Comparing positive predictive values (PPV) of using concordant PET/MRI lesion plus PI-RADS score 4~5 as positive test with PPV of using PI-RADS 4~5 alone as positive test to predict diagnosing prostate cancer within 2 years.

    Measured: 2 years after PSMA PET/MRI scan

  2. NPV of using negative PET lesion plus PI-RADS score 1~3

    Comparing negative predictive values (NPV) of using negative PET lesion plus PI-RADS score 1~3 as negative test with NPV of using PI-RADS 1~3 alone as negative test to predict diagnosing prostate cancer within 2 years.

    Measured: 2 years after PSMA PET/MRI scan

Timeline

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

  1. First posted10 Jul 2024
  2. Study start1 Jul 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
71 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06494696
Sponsor's protocol ID
202400643A3
Status last verified
Jun 2024
First submitted
2 Jul 2024
Last updated
10 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eiber M, Weirich G, Holzapfel K, Souvatzoglou M, Haller B, Rauscher I, Beer AJ, Wester HJ, Gschwend J, Schwaiger M, Maurer T. Simultaneous 68Ga-PSMA HBED-CC PET/MRI Improves the Localization of Primary Prostate Cancer. Eur Urol. 2016 Nov;70(5):829-836. doi: 10.1016/j.eururo.2015.12.053. Epub 2016 Jan 18.

    PubMed 26795686

  • Al-Bayati M, Grueneisen J, Lutje S, Sawicki LM, Suntharalingam S, Tschirdewahn S, Forsting M, Rubben H, Herrmann K, Umutlu L, Wetter A. Integrated 68Gallium Labelled Prostate-Specific Membrane Antigen-11 Positron Emission Tomography/Magnetic Resonance Imaging Enhances Discriminatory Power of Multi-Parametric Prostate Magnetic Resonance Imaging. Urol Int. 2018;100(2):164-171. doi: 10.1159/000484695. Epub 2018 Jan 25.

    PubMed 29393268

  • Muehlematter UJ, Burger IA, Becker AS, Schawkat K, Hotker AM, Reiner CS, Muller J, Rupp NJ, Ruschoff JH, Eberli D, Donati OF. Diagnostic Accuracy of Multiparametric MRI versus 68Ga-PSMA-11 PET/MRI for Extracapsular Extension and Seminal Vesicle Invasion in Patients with Prostate Cancer. Radiology. 2019 Nov;293(2):350-358. doi: 10.1148/radiol.2019190687. Epub 2019 Sep 10.

    PubMed 31502937

  • Emmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28.

    PubMed 34465492

  • Bates A, Miles K. Prostate-specific membrane antigen PET/MRI validation of MR textural analysis for detection of transition zone prostate cancer. Eur Radiol. 2017 Dec;27(12):5290-5298. doi: 10.1007/s00330-017-4877-x. Epub 2017 Jun 12.

    PubMed 28608163

  • Tang W, Tang Y, Qi L, Zhang Y, Tang G, Gao X, Hu S, Cai Y. Benign Prostatic Hyperplasia-Related False-Positive of Prostate-Specific Membrane Antigen-Positron Emission Tomography in the Diagnosis of Prostate Cancer: The Achilles' Heel of Biopsy-Free Radical Prostatectomy? J Urol. 2023 Dec;210(6):845-855. doi: 10.1097/JU.0000000000003680. Epub 2023 Aug 30.

    PubMed 37647549

  • Wong LM, Koschel S, Whish-Wilson T, Farag M, Bolton D, Zargar H, Corcoran N, Lawrentschuk N, Christov A, Thomas L, Perry E, Heinze S, Taubman K, Sutherland T. Investigating PSMA-PET/CT to resolve prostate MRI PIRADS4-5 and negative biopsy discordance. World J Urol. 2023 Feb;41(2):463-469. doi: 10.1007/s00345-022-04243-5. Epub 2023 Jan 5.

    PubMed 36602577

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Jul 2024. 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 Taiwan. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jing-Ren Tseng, MD (+886-975361314, drTsengJR@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PPV of concordant PET/MRI lesion plus PI-RADS score 4~5 (time frame: 2 years after PSMA PET/MRI scan). The study lists 2 primary outcomes in all. 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 NCT06494696, which also lists 7 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 10 Jul 2024.

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