PCAPhase 3BiPASSNCT07052214
PSMA PET Combined With MRI for the Detection of PCa
A Phase 3 study testing 68Ga-PSMA-11 in people with PCA and Prostate Cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited at 18 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- PCA, Prostate Cancer, Prostatic Neoplasm
- What is being tested?
- 68Ga-PSMA-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 18 Aug 2025to Apr 2027
- Phase
- Phase 3
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
- 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.
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- 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.
Who cannot join
- 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).
- 4. Active prostate infection, or urinary test results suggestive of an active urinary tract infection, evident on medical history, within 4 weeks of enrollment.
- 5. 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.
- 8. 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.
- 11. Have prior use of radionuclides with an interval of less than 10 effective half-lives before the administration of 68Ga-PSMA-11.
- 12. 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.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States16 sites
Urology Austin
Austin, Texas, 78759
Impression Imaging
Boca Raton, Florida, 33433
UroPartners,LLC
Chicago, Illinois, 60657
The Conrad Pearson Clinic
Germantown, Tennessee, 38138
Indiana University
Indianapolis, Indiana, 46202
Southern Urology
Lafayette, Louisiana, 70508
University of California Los Angeles
Los Angeles, California, 90095
University of Miami
Miami, Florida, 33136
Atlantic Urology Specialists
Myrtle Beach, South Carolina, 29572
Urology Associates of Nashville
Nashville, Tennessee, 37209
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Weill Cornell
New York, New York, 10065
MidLantic Urology
Philadelphia, Pennsylvania, 19004
University of California San Francisco
San Francisco, California, 94158
Washington University
St Louis, Missouri, 63110
Urology of Virginia
Virginia Beach, Virginia, 23462
Australia2 sites
Australian Prostate Centre
Melbourne N., Victoria, 3055
St Vincent's Hospital Sydney
Sydney
About this study
Official title: A Single Arm, Multicenter, Prospective, 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).
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).
Read the detailed description
This is a single arm, multicenter, prospective, open label Phase 3 study with PSMA PET for the detection of PCa. A total of 338 participants will be enrolled from approximately 25 investigative sites in the United States and Australia.
Participants with a clinical suspicion of PCa, who will undergo template biopsy, based on initial MRI (PI-RADs 3-4) within 6 months before enrollment and/or based on clinical suspicion (for PI-RADs 1-2) and who have never undergone a prostate biopsy will be eligible for the study. All participants will first undergo MRI and PSMA PET scans, followed by standard 12 core anatomical (2 core six sectors) template biopsy. If the patient does not have a biopsy, at the discretion of clinician, they'll be followed up at 6month visit. If additional lesions are detected on MRI and/or PSMA PET, MRI and/or PMSA PET targeted biopsy can be performed (according to clinician judgment).
Both MRI and/or PSMA targeted biopsies will be performed with 2 cores per lesion or as per institutional standards. Clinicians may use PSMA PET to rule out the need for biopsy, in which case, the patient will not have a histopathological SOT and will need to be followed up at 6 months. All biopsy and clinical care decisions are at the discretion of the investigator/clinician (i.e. the clinician may decide to: not biopsy, solely template biopsy, additional targeted biopsies, etc.) Participants presenting with csPCa will undergo therapy/management as per institutional standard, or according to clinician judgment.
Follow-up data will be collected for up to 6-months for participants (participants with no baseline imaging or histopathological evidence of PCa). Additional imaging, template and/or targeted biopsies may be performed during the follow-up period, at the discretion of the investigator. Any additional biopsy, imaging, clinical, histological, genetic, and intervention data will contribute to the determination of the CSOT. Follow-up will provide longitudinal surveillance to ensure that participants initially evaluated as negative for PCa on both imaging and histopathology are reliably negative.
- Conditions
- PCA, Prostate Cancer, Prostatic Neoplasm, PSMA PET, Diagnostic Imaging, Elevated PSA
- Being tested
- 68Ga-PSMA-11
- Keywords
- Molecular Imaging, Biopsy Naive, Magnetic Resonance Imaging, Biopsy, Targeted Biopsy, Radiopharmaceuticals, Cancer Detection, Urologic Oncology
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA-11Drug
Also called Illuccix, Gallium Ga 68 Gozetotide
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: 68Ga-PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start18 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Telix Innovations S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052214
- Sponsor's protocol ID
- 68Ga-TLX007-CDx-301
- Acronym
- BiPASS
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No