NCT06056830 (CLARIFY) is a Phase 3 clinical trial of 64Cu-SAR-bisPSMA in Prostate Cancer, sponsored by Clarity Pharmaceuticals Ltd.

Who is sponsoring NCT06056830?

NCT06056830 is sponsored by Clarity Pharmaceuticals Ltd.

What drugs are being tested in NCT06056830?

Interventions in NCT06056830: 64Cu-SAR-bisPSMA.

What condition does NCT06056830 study?

NCT06056830 studies Prostate Cancer, Prostatic Neoplasms.

Is NCT06056830 still recruiting?

NCT06056830 is currently recruiting now. Last updated 13 May 2026.

Last reviewed 2026-05-13 · How we verify

NCT06056830: CLARIFY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 13 May 2026

What this trial tests

Phase 3 trial testing 64Cu-SAR-bisPSMA in Prostate Cancer in 383 participants. Currently enrolling.

Timeline

21 December 2023

Primary endpoint
1 September 2026

1 September 2026

Quick facts

Lead sponsor	Clarity Pharmaceuticals Ltd
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	383
Start date	21 December 2023
Primary completion	1 September 2026
Estimated completion	1 September 2026
Sites	31 locations across United States, Australia, Puerto Rico

Drugs / interventions tested

64Cu-SAR-bisPSMA — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →
Prostatic Neoplasms — all drugs for Prostatic Neoplasms →

Sponsor

Clarity Pharmaceuticals Ltd — full company profile →

Who can join

18 and older, male only, with Prostate Cancer or Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

<sup>61</sup>Cu-PSMA-Targeted PET for Prostate Cancer: From Radiotracer Development to First-in-Human Imaging.
Basaco Bernabeu T, Mansi R, Del Pozzo L, Zanger S, et al · · 2024 · cited 11× · PMID 39025646 · DOI 10.2967/jnumed.123.267126
Development of a homotrimeric PSMA radioligand based on the NOTI chelating platform.
Martin S, Schreck MV, Stemler T, Maus S, et al · · 2024 · cited 3× · PMID 39661209 · DOI 10.1186/s41181-024-00314-7
Revolutionizing Prostate Cancer Detection: The Role of Approved PSMA-PET Imaging Agents.
Hennrich U, Wagner L, Taş H, Kovacs L, et al · · 2025 · cited 2× · PMID 40573302 · DOI 10.3390/ph18060906
Positron Emission Tomography Radiotracers for Identification of Site of Recurrence in Prostate Cancer After Primary Treatment Failure.
Bitar R, Zurita P, Martiniova L, Zurita AJ, et al · · 2025 · cited 1× · PMID 40427220 · DOI 10.3390/cancers17101723
<i>CopperNostics</i>-Here We Are Now, Entertain Us!
Brühlmann SA, Walther M, Kopka K, Kreller M, et al · · 2026 · PMID 41754861 · DOI 10.3390/ph19020321
Molecular targets and the emerging role of copper radionuclides in prostate cancer theranostics.
Rodrigues D, Fonseca AI, Moreira JN, Gomes C, et al · · 2025 · PMID 41251982 · DOI 10.1186/s13550-025-01325-4

Verify or expand the search:

Other trials of 64Cu-SAR-bisPSMA

Trials testing the same drug.

NCT06970847 — 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate C · Phase 3 · recruiting
NCT05249127 — 64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA) · Phase 1, PHASE2 · completed
NCT05286840 — 64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer · Phase 1, PHASE2 · unknown
NCT04839367 — Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPEL · Phase 1 · completed

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other Clarity Pharmaceuticals Ltd trials

Trials by the same sponsor.

NCT06970847 — 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate C · Phase 3 · recruiting
NCT05633160 — 64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing M · Phase 1, PHASE2 · terminated
NCT05407311 — 64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE) · Phase 2 · completed
NCT05249127 — 64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA) · Phase 1, PHASE2 · completed
NCT04839367 — Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPEL · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06056830 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Clarity Pharmaceuticals Ltd
Last refreshed: 13 May 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06056830.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing