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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

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En resumen

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

Fase 3383 participantes buscados34 centros3 países

Categorías

Oncología70%Nefrología y urología30%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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

Afecciones

  • Prostate Cancer
  • Prostatic Neoplasms

Elegibilidad

SexoHombre
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónNo aplicable
Modelo de intervenciónSINGLE_GROUP
Propósito principalDIAGNOSTIC
EnmascaramientoNONE (0)
Inscripción383 participantes buscados

Patrocinador y colaboradores

  • Clarity Pharmaceuticals Ltd Patrocinador

Grupos e intervenciones

  • 64Cu-SAR-bisPSMAEXPERIMENTAL

    200MBq 64Cu-SAR-bisPSMA.

Intervenciones

  • Fármaco 64Cu-SAR-bisPSMA

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

Variables de resultado

  1. Variable de resultado principal

    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.

    Plazo Up to 16 weeks

  2. Variable de resultado secundaria

    Safety and tolerability of 64Cu-SAR-bisPSMA

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

    Plazo Up to 16 weeks

  3. Variable de resultado secundaria

    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

    Plazo Up to 16 weeks

  4. Variable de resultado secundaria

    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

    Plazo Up to 16 weeks

  5. Variable de resultado secundaria

    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

    Plazo Up to 16 weeks

  6. Variable de resultado secundaria

    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

    Plazo Up to 16 weeks

Fechas

Fecha de inicio21 de diciembre de 2023 (real)
Finalización principal1 de septiembre de 2026 (estimada)
Finalización1 de septiembre de 2026 (estimada)
Primera publicación28 de septiembre de 2023 (real)
Última actualización11 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

34 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Fiona Stanley HospitalMurdochWestern AustraliaEn reclutamiento
RAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private HospitalNedlandsWestern AustraliaEn reclutamiento
St. Vincent's SydneySydneyNew South WalesEn reclutamiento
Princess Alexandra HospitalWoolloongabbaQueenslandEn reclutamiento

Puerto Rico

CentroCiudadEstado o regiónEstado
Pan American Center for Oncology Trials, LLC - CiudadelaSan JuanEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
Albany Medical College, Department of UrologyAlbanyNew YorkEn reclutamiento
Urology Austin, PLLC - Research DepartmentAustinTexasEn reclutamiento
University of Alabama Birmingham HospitalBirminghamAlabamaEn reclutamiento
University of Texas Southwestern Medical CenterDallasTexasEn reclutamiento
Urology Clinics of North TexasDallasTexasEn reclutamiento
Duke University Medical CenterDurhamNorth CarolinaEn reclutamiento
NorthShore University Health System, Glenbrook HospitalGlenviewIllinoisEn reclutamiento
BAMF HealthGrand RapidsMichiganEn reclutamiento
Corewell HealthGrand RapidsMichiganEn reclutamiento
Indiana University School of MedicineIndianapolisIndianaEn reclutamiento
Mayo Clinic- JacksonvilleJacksonvilleFloridaEn reclutamiento
Arkansas Urology Research Center, LLCLittle RockArkansasEn reclutamiento
Greater Los Angeles VA Medical CenterLos AngelesCaliforniaEn reclutamiento
Urology Group of Southern CaliforniaLos AngelesCaliforniaEn reclutamiento
University of WisconsinMadisonWisconsinEn reclutamiento
Biogenix Molecular, LLCMiamiFloridaEn reclutamiento
Intermountain HealthMurrayUtahEn reclutamiento
Carolina Urologic Research CenterMyrtle BeachSouth CarolinaEn reclutamiento
Urology Associates of NashvilleNashvilleTennesseeEn reclutamiento
Mount Sinai Doctors Urology Faculty PracticeNew YorkNew YorkEn reclutamiento
XCancer Omaha LLCOmahaNebraskaEn reclutamiento
UC Irvine HealthOrangeCaliforniaEn reclutamiento
Mayo Clinic- PhoenixPhoenixArizonaEn reclutamiento
Mayo Clinic- RochesterRochesterMinnesotaEn reclutamiento
The Urology PlaceSan AntonioTexasEn reclutamiento
Oregon UrologySpringfieldOregonEn reclutamiento
Stanford University Medical CenterStanfordCaliforniaEn reclutamiento
Urologic SpecialistsTulsaOklahomaEn reclutamiento
Wichita Urology GroupWichitaKansasEn reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 11 de septiembre de 2026

    Centro añadido

    3 sites added (34 total)

    3134

Registro: ClinicalTrials.gov · NCT########

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