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Prostate CancerNCT07386496

The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI

A study testing MRI+PSMA-guided approach and MRI-guided approach in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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

This study is a multi-center RCT to compare the clinically significant prostate cancer (csPCa) detection and/or change in clinical management in MRI guided (MRI arm) biopsy and MRI+18F-PSMA guided (Combined arm) biopsies in men with equivocal MRI prostate scans. 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?
MRI+PSMA-guided approach and MRI-guided approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteHong Kong
Study dates
7 Oct 2026to 31 Mar 2028
Phase
Interventional
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men ≥18 years of age
  • Serum Prostate-specific antigen (PSA) 4-15 ng/mL, repeated at least once
  • Prostate mpMRI done within 18 months
  • MRI prostate with PI-RADS (11) scores of:
  • PI-RADS score 2 with red flag (PSA density >0.2 OR Prostate health index, PHI>35),
  • PI-RADS 3, OR
Show all 9Show fewer
  • PI-RADS 4 with lower csPCa risks (PSAd <0.1 OR PHI<35)
  • Normal Digital rectal examination
  • Patient agrees for targeted and systematic prostate biopsy

Who cannot join

  • Prostate biopsy within past 5 years
  • Past or current history of prostate cancer
  • Contraindicated to undergo PSMA PET-CT scan
  • Contraindicated to prostate biopsy: active urinary tract infection, fail insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (keep aspirin before and after biopsy is permitted)

Trial locations and contacts

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

Peter Ka-Fung CHIU contact

+852 35052625

peterchiu@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • Prince of Wales Hospital

    Hong Kong

    Peter Ka-Fung CHIU, 852-3505 2625, peterchiu@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI: a Multi-center Randomised Controlled Trial

This study is a multi-center RCT to compare the clinically significant prostate cancer (csPCa) detection and/or change in clinical management in MRI guided (MRI arm) biopsy and MRI+18F-PSMA guided (Combined arm) biopsies in men with equivocal MRI prostate scans. If additional clinical value is shown by adding 18F-PSMA PET to equivocal MRI, then this should be the new standard of care.

Read the detailed description

The investigators propose to conduct a phase III multi-center randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-guided biopsy approach (MRI arm) versus MRI+PSMA approach (COMBINED arm). Clinically significant prostate cancer (csPCa) is defined as prostate cancer classified as ISUP (International Society of Urogenital Pathology) Grade group 2 or higher. Patients with clinical suspicion of prostate cancer on MRI with PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) score 2 with red flag (PSA density >0.2 OR Prostate health index, PHI>35), PI-RADS 3, or PI-RADS 4 (and PSAd <0.1 OR PHI<35) will be randomised in a 1:1 manner to MRI arm or COMBINED arm. The detection rates of csPCa will be compared between arms. The study hypothesis is that COMBINED arm is superior to MRI arm in detecting csPCa and changing clinical management.

Conditions
Prostate Cancer
Being tested
MRI+PSMA-guided approach, MRI-guided approach
Keywords
Prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • MRI+PSMA-guided approachProcedure or surgery

    MRI+PSMA-guided approach prostate biopsy

  • MRI-guided approachProcedure or surgery

    MRI-guided approach prostate biopsy

Study groups in NCT07386496
Study groupRoleWhat they receive
COMBINED armExperimentalIn the COMBINED arm, additional pelvis-only 18F-PSMA-1007 PET-CT is performed within 6 months from mpMRI and before biopsy. Nuclear Medicine specialist interpreting PET-CT is blinded to clinical or MRI information.
Receives: Procedure: MRI+PSMA-guided approach
MRI armActive comparatorIn the MRI arm, MRI-guided biopsy plus more than 12-core systematic biopsy will be performed.
Receives: Procedure: MRI-guided approach

What is being measured

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

  1. Proportion of men with clinically significant Prostate cancer (csPCa)

    ISUP Grade 2 or above prostate cancer diagnosed on biopsy

    Measured: When histology results available, at an expected average of 30 days post-biopsy

  2. Proportion of men with additional csPCa detected only in PET targets which will affect clinical management

    Determined by an independent and blinded panel with 3 urologists, including:

    • a change of nerve-sparing approach if radical prostatectomy is considered,
    • consideration or extent of focal therapy (partial gland ablation) of the prostate

    Measured: When histology results available, at an expected average of 30 days post-biopsy

Secondary outcomes (6)

  1. Proportion of men with csPCa detected in targeted and systematic biopsy

    ISUP Grade 2 or above prostate cancer diagnosed on biopsy

    Measured: When histology results available, at an expected average of 30 days post-biopsy

  2. Proportion of men with diagnosis of clinically insignificant prostate cancer

    ISUP grade group 1 Prostate cancer diagnosed on biopsy

    Measured: When histology results available, at an expected average of 30 days post-biopsy

  3. Proportion of men in combined arm with negative PET who could avoid a biopsy

    Measured: When PET results available, at an expected average of 7 days post-scan

  4. Correlation Between PET SUVmax of Targeted Lesion and Histologically Confirmed Clinically Significant Prostate Cancer (csPCa)

    This outcome will quantify the correlation between:

    1. SUVmax of the PET-identified target lesion Measurement Tool: PET/CT scanner Unit of Measure: SUVmax (unitless)
    2. Histopathologic confirmation of csPCa in the corresponding biopsy cores Measurement Tool: Histology assessment by certified pathologist Unit of Measure: Presence or absence of csPCa (ISUP Grade 2 or above prostate cancer)

    Measured: When histology results available, at an expected average of 30 days post-biopsy

  5. Proportion of men with post-biopsy adverse events within 30 days after biopsy

    The severity of Adverse event is grade by Clavien-Dindo classification

    Measured: 30 days post biopsy

  6. Health-related Quality of life scores

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.

    This instrument includes:

    1. Five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each scored on a 5-level scale from 1 to 5, where:
    • 1 = no problems
    • 5 = extreme problems / unable to perform (Higher scores indicate worse health status.)
    1. A Visual Analogue Scale (EQ-VAS) ranging from 0 to 100, where:
    • 0 = worst imaginable health
    • 100 = best imaginable health (Higher scores indicate better overall health.)

    Measured: Assessed at baseline and at 30 days after intervention

Timeline

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

  1. First posted4 Feb 2026
  2. Study start7 Oct 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

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 N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07386496
Sponsor's protocol ID
CRE-2025.094
Status last verified
Oct 2026
First submitted
20 Jan 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chiu PK, Teoh JY, Chan SY, Chu PS, Man CW, Hou SM, Ng CF. Role of PSA density in diagnosis of prostate cancer in obese men. Int Urol Nephrol. 2014 Dec;46(12):2251-4. doi: 10.1007/s11255-014-0826-7. Epub 2014 Sep 9.

    PubMed 25201460

  • Chiu PK, Teoh JY, Lee WM, Yee CH, Chan ES, Hou SM, Ng CF. Extended use of Prostate Health Index and percentage of [-2]pro-prostate-specific antigen in Chinese men with prostate specific antigen 10-20 ng/mL and normal digital rectal examination. Investig Clin Urol. 2016 Sep;57(5):336-42. doi: 10.4111/icu.2016.57.5.336. Epub 2016 Aug 31.

    PubMed 27617315

  • Chiu PK, Roobol MJ, Teoh JY, Lee WM, Yip SY, Hou SM, Bangma CH, Ng CF. Prostate health index (PHI) and prostate-specific antigen (PSA) predictive models for prostate cancer in the Chinese population and the role of digital rectal examination-estimated prostate volume. Int Urol Nephrol. 2016 Oct;48(10):1631-7. doi: 10.1007/s11255-016-1350-8. Epub 2016 Jun 27.

    PubMed 27349564

  • Gudmundsson J, Sulem P, Gudbjartsson DF, Masson G, Agnarsson BA, Benediktsdottir KR, Sigurdsson A, Magnusson OT, Gudjonsson SA, Magnusdottir DN, Johannsdottir H, Helgadottir HT, Stacey SN, Jonasdottir A, Olafsdottir SB, Thorleifsson G, Jonasson JG, Tryggvadottir L, Navarrete S, Fuertes F, Helfand BT, Hu Q, Csiki IE, Mates IN, Jinga V, Aben KK, van Oort IM, Vermeulen SH, Donovan JL, Hamdy FC, Ng CF, Chiu PK, Lau KM, Ng MC, Gulcher JR, Kong A, Catalona WJ, Mayordomo JI, Einarsson GV, Barkardottir RB, Jonsson E, Mates D, Neal DE, Kiemeney LA, Thorsteinsdottir U, Rafnar T, Stefansson K. A study based on whole-genome sequencing yields a rare variant at 8q24 associated with prostate cancer. Nat Genet. 2012 Dec;44(12):1326-9. doi: 10.1038/ng.2437. Epub 2012 Oct 28.

    PubMed 23104005

  • Chiu PK, Leow JJ, Chiang CH, Mok A, Zhang K, Hsieh PF, Zhu Y, Lam W, Tsang WC, Fan YH, Lin TP, Chan TY, Leung CH, Teoh JY, Chu PS, Zhu G, Ye DW, Wu HC, Tan TW, Tsu JH, Ng CF, Chiong E, Huang CY. Prostate Health Index Density Outperforms Prostate-specific Antigen Density in the Diagnosis of Clinically Significant Prostate Cancer in Equivocal Magnetic Resonance Imaging of the Prostate: A Multicenter Evaluation. J Urol. 2023 Jul;210(1):88-98. doi: 10.1097/JU.0000000000003450. Epub 2023 Apr 10.

    PubMed 37036248

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

  • Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016 Feb;40(2):244-52. doi: 10.1097/PAS.0000000000000530.

    PubMed 26492179

  • Luo L, Zheng A, Chang R, Li Y, Gao J, Wang Z, Duan X. Evaluating the value of 18F-PSMA-1007 PET/CT in the detection and identification of prostate cancer using histopathology as the standard. Cancer Imaging. 2023 Nov 3;23(1):108. doi: 10.1186/s40644-023-00627-x.

    PubMed 37924154

  • Hoffmann MA, Muller-Hubenthal J, Rosar F, Fischer N, von Eyben FE, Buchholz HG, Wieler HJ, Schreckenberger M. Primary Staging of Prostate Cancer Patients with [18F]PSMA-1007 PET/CT Compared with [68Ga]Ga-PSMA-11 PET/CT. J Clin Med. 2022 Aug 29;11(17):5064. doi: 10.3390/jcm11175064.

    PubMed 36078994

  • Prive BM, Israel B, Janssen MJR, van der Leest MMG, de Rooij M, van Ipenburg JA, Jonker M, Peters SMB, de Groot M, Zamecnik P, Hoepping A, Bomers JG, Gotthardt M, Sedelaar JPM, Barentsz JO, van Oort IM, Nagarajah J. Multiparametric MRI and 18F-PSMA-1007 PET/CT for the Detection of Clinically Significant Prostate Cancer. Radiology. 2024 May;311(2):e231879. doi: 10.1148/radiol.231879.

    PubMed 38771185

  • Margel D, Bernstine H, Groshar D, Ber Y, Nezrit O, Segal N, Yakimov M, Baniel J, Domachevsky L. Diagnostic Performance of 68Ga Prostate-specific Membrane Antigen PET/MRI Compared with Multiparametric MRI for Detecting Clinically Significant Prostate Cancer. Radiology. 2021 Nov;301(2):379-386. doi: 10.1148/radiol.2021204093. Epub 2021 Aug 31.

    PubMed 34463555

  • Buteau JP, Moon D, Fahey MT, Roberts MJ, Thompson J, Murphy DG, Papa N, Mitchell C, De Abreu Lourenco R, Dhillon HM, Kasivisvanathan V, Francis RJ, Stricker P, Agrawal S, O'Brien J, McVey A, Sharma G, Levy S, Ayati N, Nguyen A, Lee SF, Pattison DA, Sivaratnam D, Frydenberg M, Du Y, Titus J, Lee ST, Ischia J, Jack G, Hofman MS, Emmett L. Clinical Trial Protocol for PRIMARY2: A Multicentre, Phase 3, Randomised Controlled Trial Investigating the Additive Diagnostic Value of [68Ga]Ga-PSMA-11 Positron Emission Tomography/Computed Tomography in Men with Negative or Equivocal Multiparametric Magnetic Resonance Imaging for the Diagnosis of Clinically Significant Prostate Cancer. Eur Urol Oncol. 2024 Jun;7(3):544-552. doi: 10.1016/j.euo.2023.11.008. Epub 2023 Dec 6.

    PubMed 38061976

  • 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

  • Jain H, Sood R, Faridi MS, Goel H, Sharma U. Role of 68Ga-PSMA-PET/CT for the detection of primary prostate cancer prior to biopsy: a prospective study. Cent European J Urol. 2021;74(3):315-320. doi: 10.5173/ceju.2021.0084.R3. Epub 2021 Jul 8.

    PubMed 34729219

  • Padhani AR, Barentsz J, Villeirs G, Rosenkrantz AB, Margolis DJ, Turkbey B, Thoeny HC, Cornud F, Haider MA, Macura KJ, Tempany CM, Verma S, Weinreb JC. PI-RADS Steering Committee: The PI-RADS Multiparametric MRI and MRI-directed Biopsy Pathway. Radiology. 2019 Aug;292(2):464-474. doi: 10.1148/radiol.2019182946. Epub 2019 Jun 11.

    PubMed 31184561

Questions about this trial

What is this clinical trial studying?

A study testing MRI+PSMA-guided approach and MRI-guided approach in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 9 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 27 Oct 2026. 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 Hong Kong. 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 Peter Ka-Fung CHIU (+852 35052625, peterchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of men with clinically significant Prostate cancer (csPCa) (time frame: When histology results available, at an expected average of 30 days post-biopsy). 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 NCT07386496, which also lists 27 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 27 Oct 2026.

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