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NCT04868604: SECuRE

A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer

Recruiting now Phase 1/Phase 2 Last updated 4 May 2026
What this trial tests

Phase 1/Phase 2 trial testing 64Cu-SAR-bisPSMA in Prostatic Neoplasms, Castration-Resistant in 54 participants. Currently enrolling.

Timeline
11 August 2021
Primary endpoint
1 September 2026
1 September 2026

Quick facts

Lead sponsorClarity Pharmaceuticals Ltd
PhasePhase 1/Phase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment54
Start date11 August 2021
Primary completion1 September 2026
Estimated completion1 September 2026
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Clarity Pharmaceuticals Ltd — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms, Castration-Resistant. 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.

Sponsor's own description

The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Publications & conference data

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

  1. PSMA PET/CT: joint EANM procedure guideline/SNMMI procedure standard for prostate cancer imaging 2.0.
    Fendler WP, Eiber M, Beheshti M, Bomanji J, et al · · 2023 · cited 261× · PMID 36604326 · DOI 10.1007/s00259-022-06089-w
  2. Joint EANM/SNMMI procedure guideline for the use of <sup>177</sup>Lu-labeled PSMA-targeted radioligand-therapy (<sup>177</sup>Lu-PSMA-RLT).
    Kratochwil C, Fendler WP, Eiber M, Hofman MS, et al · · 2023 · cited 171× · PMID 37246997 · DOI 10.1007/s00259-023-06255-8
  3. Radiopharmaceuticals and their applications in medicine.
    Zhang S, Wang X, Gao X, Chen X, et al · · 2025 · cited 113× · PMID 39747850 · DOI 10.1038/s41392-024-02041-6
  4. Appropriate Use Criteria for Prostate-Specific Membrane Antigen PET Imaging.
    Jadvar H, Calais J, Fanti S, Feng F, et al · · 2022 · cited 95× · PMID 34593595 · DOI 10.2967/jnumed.121.263262
  5. Biological determinants of PSMA expression, regulation and heterogeneity in prostate cancer.
    Bakht MK, Beltran H. · · 2025 · cited 87× · PMID 38977769 · DOI 10.1038/s41585-024-00900-z
  6. PSMA-Targeted Radiopharmaceuticals in Prostate Cancer: Current Data and New Trials.
    Ramnaraign B, Sartor O. · · 2023 · cited 49× · PMID 36806966 · DOI 10.1093/oncolo/oyac279
  7. Recent Advances in <sup>64</sup>Cu/<sup>67</sup>Cu-Based Radiopharmaceuticals.
    Krasnovskaya OO, Abramchuck D, Erofeev A, Gorelkin P, et al · · 2023 · cited 32× · PMID 37298101 · DOI 10.3390/ijms24119154
  8. Radiolabeled PSMA Inhibitors.
    Neels OC, Kopka K, Liolios C, Afshar-Oromieh A. · · 2021 · cited 28× · PMID 34944875 · DOI 10.3390/cancers13246255

Verify or expand the search:

Other trials of 64Cu-SAR-bisPSMA

Trials testing the same drug.

Other recruiting trials for Prostatic Neoplasms, Castration-Resistant

Currently open trials in the same condition.

Other Clarity Pharmaceuticals Ltd trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04868604.

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