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Prostate CancerPhase 3CLARIFYNCT06056830

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

A Phase 3 study testing 64Cu-SAR-bisPSMA in people with Prostate Cancer and Prostatic Neoplasms, run by Clarity Pharmaceuticals Ltd at 34 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Prostatic Neoplasms
What is being tested?
64Cu-SAR-bisPSMA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
383 participants
Where
34 sitesin 3 countries
Study dates
21 Dec 2023to Sep 2026
Phase
Phase 3
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

  • At least 18 years of age.
  • Signed informed consent.
  • Untreated, histologically confirmed adenocarcinoma of the prostate.
  • High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
  • Patients electing to undergo RP with PLND.

Who cannot join

  • Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
  • Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  • Patients with known predominant small cell or neuroendocrine PC.

Trial locations and contacts

34 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Clarity Pharmaceuticals contact

+61 (0) 2 9209 4037

clinicaltrials@claritypharmaceuticals.com

34 sites in 3 countries

United States29 sites, 29 recruiting

  • Albany Medical College, Department of Urology

    Albany, New York, 12208

    Ronald Kaufman, MD, 518-262-8579, AMCUrologyResearch@amc.edu

    Ronald Kaufman, MD

    Recruiting

  • Urology Austin, PLLC - Research Department

    Austin, Texas, 78759

    Jennifer Penshorn, RN, CCRC, 512-410-3773, jennifer.penshorn@urologyaustin.com

    Michael Egenes, 512-410-3773, Michael.Egenes@urologyaustin.com

    Recruiting

  • University of Alabama Birmingham Hospital

    Birmingham, Alabama, 35249-6830

    Ashley Barnes, 205-996-5784, alstrickland@uabmc.edu

    Sebastian Eady, 205-996-2636, smeady@uabmc.edu

    Recruiting

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

    Alexander Parker, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8896

    Orhan Oz, MD, 214-645-1568, RCRO@UTSouthwestern.edu

    Radiology Clinical Research Office

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Alex Sents, MA, MPH, (919) 668-0739, alex.sents@duke.edu

    Terence Z Wong, MD, PhD, FACR

    Recruiting

  • NorthShore University Health System, Glenbrook Hospital

    Glenview, Illinois, 60026

    Brian Helfand, MD

    Recruiting

  • BAMF Health

    Grand Rapids, Michigan, 49503

    Clayton McNamara, ResearchClinicalTeam@bamfhealth.com

    Harshad Kulkarni, MD

    Recruiting

  • Corewell Health

    Grand Rapids, Michigan, 49503

    Josh Dejong, 616-267-7566, joshua.dejong@corewellhealth.org

    Rachel Schmidt, BSN, RN, 616-486-1545, rachel.schmidt@corewellhealth.org

    Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

    Ashlee Frazee, PhD, (317)278-4959, amfrazee@iu.edu

    Clint D Bahler, MD

    Recruiting

  • Mayo Clinic- Jacksonville

    Jacksonville, Florida, 32224

    Ephraim Parent, MD

    Recruiting

  • Arkansas Urology Research Center, LLC

    Little Rock, Arkansas, 72211

    Katie, 5012198900 ext. 9039, research@arkansasurology.com

    Sarah, 5012198900 ext. 2002, research@arkansasurology.com

    Recruiting

  • Urology Group of Southern California

    Los Angeles, California, 90017

    Carlos Lopez, clopez@folioclinicalresearch.com

    Yvette Zuniga, yzuniga@folioclinicalresearch.com

    Recruiting

  • Greater Los Angeles VA Medical Center

    Los Angeles, California, 90073

    Gholam R. Berenji, MD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53705

    Nandakumar Menon, MD

    Recruiting

  • Biogenix Molecular, LLC

    Miami, Florida, 33165

    Jerry Joseph, FMD, 786-791-1799, jjoseph@cira-health.com

    Cesar A Santana, MD, PhD

    Recruiting

  • Intermountain Health

    Murray, Utah, 84107

    Dustin L. Boothe, MD

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Neal Shore, MD

    Recruiting

  • Urology Associates of Nashville

    Nashville, Tennessee, 37209

    David Morris, MD

    Recruiting

  • Mount Sinai Doctors Urology Faculty Practice

    New York, New York, 10029

    Monali Fatterpekar, 212-241-9955, monali.fatterpekar@mountsinai.org

    Ashutosh Tewari, MD

    Recruiting

  • XCancer Omaha LLC

    Omaha, Nebraska, 68130

    Tony Romero, 402-991-8468, tromero@gucancer.com

    Luke Nordquist, MD

    Recruiting

  • UC Irvine Health

    Orange, California, 92868

    877-827-8839, ucstudy@hs.uci.edu

    Edward Uchio, MD, FACS, CPI

    Recruiting

  • Mayo Clinic- Phoenix

    Phoenix, Arizona, 85054

    Jack Andrews, MD

    Recruiting

  • Mayo Clinic- Rochester

    Rochester, Minnesota, 55905

    Jeffrey Karnes, MD

    Recruiting

  • The Urology Place

    San Antonio, Texas, 78240

    Naveen Kella, MD

    Recruiting

  • Oregon Urology

    Springfield, Oregon, 97477

    Bryan Mehllhaff, MD

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94305-5105

    Hong Song, MD, PhD

    Recruiting

  • Urologic Specialists

    Tulsa, Oklahoma, 74146

    Shaun GS Grewal, MD

    Recruiting

  • Wichita Urology Group

    Wichita, Kansas, 67226

    Timothy Richardson, MD, 316-636-6141

    Tyler Gentry, CCRC, 316-636-6141, TGENTRY@WichitaUrology.com

    Recruiting

Other trials in United States

Australia4 sites, 4 recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

    Dickon Hayne, MD

    Recruiting

  • RAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private Hospital

    Nedlands, Western Australia, 6009

    Eilish McCarthy, 08 9346 6022, McCarthyEilish@ramsayhealth.com.au

    Sally Cronan, 08 9346 6022, cronans@ramsayhealth.com.au

    Recruiting

  • St. Vincent's Sydney

    Sydney, New South Wales

    Louise Emmett, MD

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

    Ian Vela, MD

    Recruiting

Other trials in Australia

Puerto Rico1 site, 1 recruiting

  • Pan American Center for Oncology Trials, LLC - Ciudadela

    San Juan, 00918

    Christina De La Cruz, Lead CRC, 787-407-3333, Christina.delacruz@panoncologytrials.com

    Isamar Alicea (Site Manager), Dra., 787-407-3333, Isamar.alicea@panoncologytrials.com

    Recruiting

Other trials in Puerto Rico

About this study

Official title: Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Being tested
64Cu-SAR-bisPSMA
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • 64Cu-SAR-bisPSMADrug

    All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

Study groups in NCT06056830
Study groupRoleWhat they receive
64Cu-SAR-bisPSMAExperimental200MBq 64Cu-SAR-bisPSMA.
Receives: Drug: 64Cu-SAR-bisPSMA

What is being measured

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

  1. Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases

    Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.

    Measured: Up to 16 weeks

Secondary outcomes (5)

  1. Safety and tolerability of 64Cu-SAR-bisPSMA

    Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA

    Measured: Up to 16 weeks

  2. Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers

    Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic

    Measured: Up to 16 weeks

  3. PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs

    PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth

    Measured: Up to 16 weeks

  4. Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer

    Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth

    Measured: Up to 16 weeks

  5. Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching

    Sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth, without the requirement of subregion (Left or Right) matching between 64Cu-SAR-bisPSMA PET and Standard of Truth

    Measured: Up to 16 weeks

Timeline

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

  1. First posted28 Sep 2023
  2. Study start21 Dec 2023
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
383 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06056830
Sponsor's protocol ID
CLP04
Acronym
CLARIFY
Status last verified
Sep 2026
First submitted
21 Sep 2023
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 64Cu-SAR-bisPSMA in people with Prostate Cancer and Prostatic Neoplasms, run by Clarity Pharmaceuticals Ltd at 34 sites in 3 countries.

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 5 inclusion and 3 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Australia, Puerto Rico. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Clarity Pharmaceuticals (+61 (0) 2 9209 4037, clinicaltrials@claritypharmaceuticals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases (time frame: Up to 16 weeks). 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 NCT06056830.

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 11 Sep 2026.

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