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

NCT06494696 | Recruiting

• 1 other identifier: 202400643A3
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does PSMA PET/MRI have better PPV and NPV than mpMRI to diagnose prostate cancer?
2. 2.Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy?
3. 3.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.
4. 4.Between the follow-up period, visit the clinic once every 6 months for checkups and blood tests.

Conditions

Prostate Cancer

Keywords

Ga-68 PSMA PET/MRI; PI-RADS; Biopsy naive

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years after PSMA PET/MRI scan

• 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.

  2 years after PSMA PET/MRI scan

Study Arms (1)

Experimental

Diagnostic Test: Ga-68 PSMA PET/MRI

Interventions

Ga-68 PSMA PET/MRI DIAGNOSTIC_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.

Experimental

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council: collaborator

Study Sites (1)

Chang Gung Memorial Hospital ,Linkou

Taoyuan, 333, Taiwan

RECRUITING

Related Publications (7)

• 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.

  PMID: 26795686 BACKGROUND

• 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.

  PMID: 29393268 BACKGROUND

• 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.

  PMID: 31502937 BACKGROUND

• 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.

  PMID: 34465492 BACKGROUND

• 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.

  PMID: 28608163 BACKGROUND

• 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.

  PMID: 37647549 BACKGROUND

• 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.

  PMID: 36602577 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jing-Ren Tseng, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Ren Tseng, MD

CONTACT

+886-975361314; drTsengJR@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)