PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI

NCT05154162 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 20/043
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 6

Brief Summary

This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; PSMA PET

Outcome Measures

Primary Outcomes (2)

• Presence of sPCa on prostate biopsy

  sPCa defined as Gleason score 3+4(\>10%)=7, Grade group 2 Patients without biopsy (negative PSMA PET) are considered not to have sPCa.

  When histology results are available, at an expected average of 14 days post-biopsy

• Number of men who avoid transperineal prostate biopsy in the experimental arm

  In the experimental arm, if PSMA PET is negative, the patient does not have biopsy

  When the PSMA PET result is available, at most 28 days after randomisation

Secondary Outcomes (9)

• Presence of insignificant prostate cancer (isPCa) on prostate biopsy

  Within 3 months following randomisation

• Cost per quality adjusted life year

  Through study completion, estimated up to 2 years

• Health-related quality of life as measured by the EORTC QLQ-C30.

  Within 7 days of randomisation and every 6 months ± 30 days after randomisation

• Anxiety as measured by the GAD7 in the diagnosis of PCa.

  Within 7 days following randomisation and every 6 months ± 30 days after randomisation

• Cancer worry in the diagnosis of PCa.

  Within 7 days following randomisation and every 6 months ± 30 days after randomisation

Study Arms (2)

Experimental

EXPERIMENTAL

Pelvic PSMA PET ± transperineal targeted prostate biopsy

Diagnostic Test: PSMA PET/CT; Procedure: Transperineal targeted prostate biopsy

Control

OTHER

No pelvic PSMA PET + transperineal template prostate biopsy

Procedure: Transperineal template prostate biopsy

Interventions

PSMA PET/CT DIAGNOSTIC_TEST

PSMA PET/CT (limited to the pelvis)

Experimental

Transperineal template prostate biopsy PROCEDURE

Transperineal template prostate biopsies will be performed as per treating urologist's usual practice. No specific template for biopsy is prescribed for the purposes of the study. However, template sampling of the prostate is required, with a minimum of 12 cores, dependent on prostate volume. MRI will be available for any additional targeted biopsies required. Transperineal template biopsies must be labelled appropriately and sent for histopathological analysis.

Control

Transperineal targeted prostate biopsy PROCEDURE

If the PSMA PET/CT is normal, transperineal prostate biopsy would be omitted If the PSMA PET/CT is abnormal, transperineal prostate biopsies would be performed targeting the MRI (done prior to study) and PSMA PET/CT images

Experimental

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males aged ≥ 18 years at the time of consent
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all the following criteria for study entry:
• Males aged ≥ 18 years at the time of consent
• No previously diagnosed prostate cancer
• No previous prostate biopsy
• Having undergone MRI within 9 months prior to randomisation and meet one of the following criteria:
• PI-RADS 2 AND ≥1 red flag defined as:
• PSA density \>0.1
• Abnormal DRE
• Strong family history (1 first degree relative or ≥2 second degree)
• BRCA mutation
• PSA \>10
• PSA doubling time \<36 months
• PSA velocity \>0.75/year
• PI-RADS 3
• Intention for prostate biopsy

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry:
• Having a PSA \>20ng/ml
• Having ≥ cT3 on DRE
• Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• St Vincent's Hospital, Sydney: collaborator

Study Sites (6)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4006, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Cabrini Health

Melbourne, Victoria, 3144, Australia

Location

Related Publications (2)

• Emmett L, Papa N, Hope TA, Fendler W, Calais J, Burger I, Eiber M, Barbato F, Moon D, Counter W, John N, Xue A, Franklin A, Thompson J, Rasiah K, Frydenberg M, Yaxley J, Buteau J, Agrawal S, Ho B, Nguyen A, Liu V, Lee J, Woo H, Hsiao E, Sutherland T, Perry E, Stricker P, Hofman MS, Kasivisvanathan V, Roberts M, Murphy D. Beyond Prostate Imaging Reporting and Data System: Combining Magnetic Resonance Imaging Prostate Imaging Reporting and Data System and Prostate-Specific Membrane Antigen-Positron Emission Tomography/Computed Tomography PRIMARY Score in a Composite (P) Score for More Accurate Diagnosis of Clinically Significant Prostate Cancer. J Urol. 2024 Aug;212(2):299-309. doi: 10.1097/JU.0000000000004010. Epub 2024 May 17.

  PMID: 38758680 DERIVED

• 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.

  PMID: 38061976 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Hofman

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

• Louise Emmett

  St Vincent's Sydney

  PRINCIPAL INVESTIGATOR

• Mark Frydenberg

  Cabrini Health

  PRINCIPAL INVESTIGATOR

• Sze-Ting Lee

  Austin Health

  PRINCIPAL INVESTIGATOR

• Matthew Roberts

  Royal Brisbane and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Yang Du

  Royal Adelaide Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: December 10, 2021
• Study Start: March 2, 2022
• Primary Completion: December 15, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (6)