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NCT06056830ClinicalTrials.gov

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

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

RecruitingTaking participants now, according to the registry record.
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In brief

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

Phase 3383 participants sought34 sites3 countries

Categories

Oncology70%Nephrology & urology30%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2023-09-28; recorded start 2023-12-21
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 4 other studies in this databaseCounted from the lead sponsor named in the record (Clarity Pharmaceuticals Ltd)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 31 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 383 participants (target), run at 34 sites, across 3 countries.

How this score is built
  • Enrolment25/40

    383 participants (target)

  • Site count18/25

    31 sites

  • Country count7/15

    3 countries

  • Planned duration8/10

    Planned over about 33 months

  • Sponsor scale2/10

    Clarity Pharmaceuticals Ltd has led 5 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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

Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Eligibility

SexMale
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 3
AllocationNot applicable
Intervention modelSINGLE_GROUP
Primary purposeDIAGNOSTIC
MaskingNONE (0)
Enrolment383 participants sought

Sponsor and collaborators

  • Clarity Pharmaceuticals Ltd Sponsor

Arms and interventions

  • 64Cu-SAR-bisPSMAEXPERIMENTAL

    200MBq 64Cu-SAR-bisPSMA.

Interventions

  • Drug 64Cu-SAR-bisPSMA

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

Outcome measures

  1. Primary outcome

    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.

    Time frame Up to 16 weeks

  2. Secondary outcome

    Safety and tolerability of 64Cu-SAR-bisPSMA

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

    Time frame Up to 16 weeks

  3. Secondary outcome

    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

    Time frame Up to 16 weeks

  4. Secondary outcome

    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

    Time frame Up to 16 weeks

  5. Secondary outcome

    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

    Time frame Up to 16 weeks

  6. Secondary outcome

    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

    Time frame Up to 16 weeks

Dates

Start dateDecember 21, 2023 (actual)
Primary completionSeptember 1, 2026 (estimated)
CompletionSeptember 1, 2026 (estimated)
First postedSeptember 28, 2023 (actual)
Last updatedSeptember 11, 2026
Results postedNot stated in the registry record
Status last verifiedSeptember 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

34 sites are recruiting

Australia

FacilityCityState or regionStatus
Fiona Stanley HospitalMurdochWestern AustraliaRecruiting
RAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private HospitalNedlandsWestern AustraliaRecruiting
St. Vincent's SydneySydneyNew South WalesRecruiting
Princess Alexandra HospitalWoolloongabbaQueenslandRecruiting

Puerto Rico

FacilityCityState or regionStatus
Pan American Center for Oncology Trials, LLC - CiudadelaSan JuanRecruiting

United States

FacilityCityState or regionStatus
Albany Medical College, Department of UrologyAlbanyNew YorkRecruiting
Urology Austin, PLLC - Research DepartmentAustinTexasRecruiting
University of Alabama Birmingham HospitalBirminghamAlabamaRecruiting
University of Texas Southwestern Medical CenterDallasTexasRecruiting
Urology Clinics of North TexasDallasTexasRecruiting
Duke University Medical CenterDurhamNorth CarolinaRecruiting
NorthShore University Health System, Glenbrook HospitalGlenviewIllinoisRecruiting
BAMF HealthGrand RapidsMichiganRecruiting
Corewell HealthGrand RapidsMichiganRecruiting
Indiana University School of MedicineIndianapolisIndianaRecruiting
Mayo Clinic- JacksonvilleJacksonvilleFloridaRecruiting
Arkansas Urology Research Center, LLCLittle RockArkansasRecruiting
Greater Los Angeles VA Medical CenterLos AngelesCaliforniaRecruiting
Urology Group of Southern CaliforniaLos AngelesCaliforniaRecruiting
University of WisconsinMadisonWisconsinRecruiting
Biogenix Molecular, LLCMiamiFloridaRecruiting
Intermountain HealthMurrayUtahRecruiting
Carolina Urologic Research CenterMyrtle BeachSouth CarolinaRecruiting
Urology Associates of NashvilleNashvilleTennesseeRecruiting
Mount Sinai Doctors Urology Faculty PracticeNew YorkNew YorkRecruiting
XCancer Omaha LLCOmahaNebraskaRecruiting
UC Irvine HealthOrangeCaliforniaRecruiting
Mayo Clinic- PhoenixPhoenixArizonaRecruiting
Mayo Clinic- RochesterRochesterMinnesotaRecruiting
The Urology PlaceSan AntonioTexasRecruiting
Oregon UrologySpringfieldOregonRecruiting
Stanford University Medical CenterStanfordCaliforniaRecruiting
Urologic SpecialistsTulsaOklahomaRecruiting
Wichita Urology GroupWichitaKansasRecruiting

Study documents

No documents are linked in this registry record.

Changes over time

  1. September 11, 2026

    Site added

    3 sites added (34 total)

    3134

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06056830