NCT07052214

Brief Summary

This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P50-P75 for phase_3

Timeline
8mo left

Started Aug 2025

Geographic Reach
2 countries

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Aug 2025Apr 2027

First Submitted

Initial submission to the registry

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

June 26, 2025

Last Update Submit

July 22, 2026

Conditions

PCAProstate CancerProstatic NeoplasmPSMA PETDiagnostic ImagingElevated PSAPositron Emission TomographyProstate BiopsyCarcinoma of the Prostate

Keywords

Molecular ImagingBiopsy NaiveMagnetic Resonance ImagingBiopsyTargeted BiopsyRadiopharmaceuticalsCancer DetectionUrologic Oncology

Outcome Measures

Primary Outcomes (2)

  • Primary Objective

    To evaluate the diagnostic performance of combined 68Ga-PSMA-11 PET and MRI targeted biopsy for the detection of PCa, using histopathological confirmation as the SOT.

    12 months

  • Co-Primary Endpoint

    To assess the sensitivity and specificity of 68Ga-PSMA-11 PET as adjunct to MRI or the detection of PCa, confirmed by predefined standard of truth (SOT).

    12 months

Study Arms (1)

Illuccix: 68Ga-PSMA-11/Gallium Ga 68 Gozetotide

OTHER

This is a single arm study. All participants will first undergo mpMRI and PSMA PET scans (one single IV bolus of Gallium Ga 68 Gozetotide administered)

Drug: 68Ga-PSMA-11

Interventions

68Ga-PSMA-11DRUG

The radioconjugate 68Ga-PSMA-11 is composed of a human PSMA-targeting ligand peptide conjugated via the acyclic radiometal chelator, N, N'-bis \[2-hydroxy-5-(carboxyethyl)benzyl\] ethylenediamine-N, N'-diacetic acid (HBED-CC) to the radioisotope Gallium68 ( 68Ga); which binds to PSMA on the surface of cells expressing PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. 68Ga is a β+ (beta) ray emitting radionuclide that allows precise imaging via PET.

Also known as: Illuccix, Gallium Ga 68 Gozetotide
Illuccix: 68Ga-PSMA-11/Gallium Ga 68 Gozetotide

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate Cancer is for Males only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male, at least 18 years old.
  • Have a clinical suspicion of csPCa, and indicated for template biopsy after having received an MRI demonstrating PI-RADs 1 to 4 within 6 months of enrollment and/or have non-imaging risk factors (including but not exclusive to):
  • a) Persistently elevated or rising PSA b) High PSA density c) Abnormal digital rectal examination (DRE) d) Strong family history of prostate cancer: i. First-degree relative (father or brother) with csPCa ii. Any relative diagnosed at \<65 years of age iii. Multiple affected relatives iv. Known hereditary cancer syndromes (e.g. BReast CAncer gene \[BRCA\]1/2, Homeobox protein Hox-B13 \[HOXB13\] mutations) e) Other high-risk biomarkers: i. 4Kscore ii. PHI (Prostate Health Index) iii. High Prostate Cancer Antigen 3 (PCA3) iv. Any other established biomarker with values in the high-risk range f) Clinical presentation: i. Symptoms suggestive of locally advanced disease (e.g. urinary obstruction, bone pain) ii. Prior negative MRI with ongoing clinical concern
  • Prostate biopsy naïve.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines.
  • Have the capacity to understand the study and be able and willing to comply with all protocol requirements.
  • Provides consent for anatomical template with/without targeted biopsy based on clinical risk, MRI and PSMA PET result.
  • Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant.
  • Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, (CTFG \[Clinical Trial Facilitation Group\], 2020). Details of contraceptive measures to be taken by male participants and their female partners are described in Appendix 4 of the Protocol.

You may not qualify if:

  • Participants are excluded from the study if any of the following criteria apply:
  • Has prior diagnosis of csPCa
  • Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy).
  • \. Active prostate infection, or urinary test results suggestive of an active urinary tract infection, evident on medical history, within 4 weeks of enrollment.
  • \. Prior pelvic irradiation 6. Demonstrate radiographic findings of PI-RADS 5. 7. Has abnormalities in physical examination and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance; and/or is deemed not suitable for participating in this trial in the opinion of the investigator.
  • \. Unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the investigator. 9. Is unable to attain or remain in a supine position while a PET/CT scan is being performed or unable to tolerate a PET/CT scan 10. Unable or unwilling to undergo clinical prostate biopsy, has known allergies, hypersensitivity, or intolerance to the investigational drug/comparator or its excipients.
  • \. Have prior use of radionuclides with an interval of less than 10 effective half-lives before the administration of 68Ga-PSMA-11.
  • \. Is participating or plans to participate in any experimental drug or device trial during the study period that are considered outside of therapeutic SOC. Studies involving modifications of sequencing or timing of therapeutic regimens/interventions would be deemed eligible to enroll.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Impression Imaging

Boca Raton, Florida, 33433, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

UroPartners,LLC

Chicago, Illinois, 60657, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Southern Urology

Lafayette, Louisiana, 70508, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Weill Cornell

New York, New York, 10065, United States

RECRUITING

MidLantic Urology

Philadelphia, Pennsylvania, 19004, United States

RECRUITING

Atlantic Urology Specialists

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

The Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States

RECRUITING

Urology Associates of Nashville

Nashville, Tennessee, 37209, United States

RECRUITING

Urology Austin

Austin, Texas, 78759, United States

RECRUITING

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

RECRUITING

Australian Prostate Centre

Melbourne N., Victoria, 3055, Australia

RECRUITING

St Vincent's Hospital Sydney

Sydney, Australia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 4, 2025

Study Start

August 18, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations

AU(2)US(16)