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NCT06907641: Co-PSMA
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
Phase 2 trial testing 64Cu-SAR-bisPSMA in Prostate Cancer (Post Prostatectomy) in 50 participants. Currently enrolling.
1 November 2025
Quick facts
| Lead sponsor | St Vincent's Hospital, Sydney |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 50 |
| Start date | 21 November 2024 |
| Primary completion | 1 November 2025 |
| Estimated completion | 1 November 2025 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- 64Cu-SAR-bisPSMA — full drug profile →
Conditions studied
- Prostate Cancer (Post Prostatectomy) — all drugs for Prostate Cancer (Post Prostatectomy) →
Sponsor
St Vincent's Hospital, Sydney
Who can join
18 and older, male only, with Prostate Cancer (Post Prostatectomy). 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.
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Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT
Time frame: 12 months
Compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT in patients with biochemical recurrence following radical prostatectomy who are being considered for curative salvage radiotherapy.
Sponsor's own description
The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are: * Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans. * What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator. * Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11). Participants will: * have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only * have standard of care blood test either at Visit 1 or Visit 2
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Prospective Comparison of <sup>64</sup>Copper [<sup>64</sup>Cu]SAR-bisPSMA vs <sup>68</sup>Gallium[<sup>68</sup>Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial).
Khan S, Papa N, Kneebone A, Eade T, et al · · 2026 · cited 1× · PMID 41904043 · DOI 10.1016/j.eururo.2026.03.001 -
<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:
- PubMed search for NCT06907641
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 (Post Prostatectomy)
Currently open trials in the same condition.
- NCT07520916 — The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatec · NA · recruiting
- NCT07477626 — Radiotherapy After Prostatectomy for Node Positive Prostate Cancer · Phase 3 · active not recruiting
- NCT07484971 — Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria · recruiting
- NCT06687538 — Effect of Education to be Provided to Patients to Undergo TURP With Mobile Application on Patient Outcomes · NA · recruiting
- NCT06850116 — Analysis of Immediate Urinary Continence Predictors After RS-RARP · active not recruiting
Other St Vincent's Hospital, Sydney trials
Trials by the same sponsor.
- NCT07203391 — Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis · Phase 1 · recruiting
- NCT05889728 — Pilot Trial to Assess 68Ga Bombesin PET/CT (NeoB) Imaging for Staging of Breast Cancer · Phase 2 · unknown
- NCT05613842 — Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer (BOP) · Phase 2 · completed
- NCT05187884 — Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma · Phase 2 · active not recruiting
- NCT04925648 — Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06907641 (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 St Vincent's Hospital, Sydney
- Last refreshed: 1 April 2025
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/NCT06907641.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing