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
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
Registered in 1 registry
- ClinicalTrials.govNCT06056830Open this record at ClinicalTrials.govSynced last week
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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.
- Present: Registered before enrolment beganFirst posted 2023-09-28; recorded start 2023-12-21
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
- Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: 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.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 4 other studies in this databaseCounted from the lead sponsor named in the record (Clarity Pharmaceuticals Ltd)
- Not stated: 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.
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.
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
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
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
| Sex | Male |
|---|---|
| Ages | 18 Years – No maximum |
| Healthy volunteers | No |
Eligibility as written in the registry
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 type | Interventional |
|---|---|
| Phase | Phase 3 |
| Allocation | Not applicable |
| Intervention model | SINGLE_GROUP |
| Primary purpose | DIAGNOSTIC |
| Masking | NONE (0) |
| Enrolment | 383 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
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
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
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
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
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
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 date | December 21, 2023 (actual) |
|---|---|
| Primary completion | September 1, 2026 (estimated) |
| Completion | September 1, 2026 (estimated) |
| First posted | September 28, 2023 (actual) |
| Last updated | September 11, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | September 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
34 sites are recruiting
Australia
| Facility | City | State or region | Status |
|---|---|---|---|
| Fiona Stanley Hospital | Murdoch | Western Australia | Recruiting |
| RAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private Hospital | Nedlands | Western Australia | Recruiting |
| St. Vincent's Sydney | Sydney | New South Wales | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Recruiting |
Puerto Rico
| Facility | City | State or region | Status |
|---|---|---|---|
| Pan American Center for Oncology Trials, LLC - Ciudadela | San Juan | Recruiting |
United States
| Facility | City | State or region | Status |
|---|---|---|---|
| Albany Medical College, Department of Urology | Albany | New York | Recruiting |
| Urology Austin, PLLC - Research Department | Austin | Texas | Recruiting |
| University of Alabama Birmingham Hospital | Birmingham | Alabama | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| Urology Clinics of North Texas | Dallas | Texas | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| NorthShore University Health System, Glenbrook Hospital | Glenview | Illinois | Recruiting |
| BAMF Health | Grand Rapids | Michigan | Recruiting |
| Corewell Health | Grand Rapids | Michigan | Recruiting |
| Indiana University School of Medicine | Indianapolis | Indiana | Recruiting |
| Mayo Clinic- Jacksonville | Jacksonville | Florida | Recruiting |
| Arkansas Urology Research Center, LLC | Little Rock | Arkansas | Recruiting |
| Greater Los Angeles VA Medical Center | Los Angeles | California | Recruiting |
| Urology Group of Southern California | Los Angeles | California | Recruiting |
| University of Wisconsin | Madison | Wisconsin | Recruiting |
| Biogenix Molecular, LLC | Miami | Florida | Recruiting |
| Intermountain Health | Murray | Utah | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | Recruiting |
| Urology Associates of Nashville | Nashville | Tennessee | Recruiting |
| Mount Sinai Doctors Urology Faculty Practice | New York | New York | Recruiting |
| XCancer Omaha LLC | Omaha | Nebraska | Recruiting |
| UC Irvine Health | Orange | California | Recruiting |
| Mayo Clinic- Phoenix | Phoenix | Arizona | Recruiting |
| Mayo Clinic- Rochester | Rochester | Minnesota | Recruiting |
| The Urology Place | San Antonio | Texas | Recruiting |
| Oregon Urology | Springfield | Oregon | Recruiting |
| Stanford University Medical Center | Stanford | California | Recruiting |
| Urologic Specialists | Tulsa | Oklahoma | Recruiting |
| Wichita Urology Group | Wichita | Kansas | Recruiting |
Study documents
No documents are linked in this registry record.
Changes over time
- September 11, 2026
Site added
3 sites added (34 total)
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