CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
64Cu-SAR-BBNdrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically confirmed adenocarcinoma of prostate with completed definitive therapy (prostatectomy, radiation, cryotherapy, or brachytherapy)
  • ✓Biochemical recurrence: detectable/rising PSA ≥0.2 ng/mL post-prostatectomy (with confirmatory PSA ≥0.2 ng/mL), or PSA elevation ≥2 ng/mL above nadir post-radiation/cryotherapy/brachytherapy
  • ✓Negative or equivocal findings on approved PSMA PET, anatomical imaging (CT and/or MRI), and other conventional imaging within 60 days prior to study entry
  • ✓ECOG performance status 0-2
Key exclusion· 5
  • ✕Ongoing systemic therapy (ADT, antiandrogen, GnRH agonist/antagonist) within 90 days of study entry
  • ✕Expected to require prohibitive treatment (e.g., ADT initiation due to rapidly rising PSA) before 64Cu-SAR-BBN PET results can be verified
  • ✕Receipt of other investigational agents within 28 days of study entry
  • ✕Administration of high-energy (>300 keV) gamma-emitting radioisotope within 5 physical half-lives of study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05407311
NCT05407311Phase 2Completed
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64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer

Clarity Pharmaceuticals Ltd·interventional·Posted Jun 7, 2022·Updated Nov 17, 2025

In Brief

A Phase 2 clinical trial evaluating 64Cu-SAR-BBN for Biochemical Recurrence of Malignant Neoplasm of Prostate. Completed, enrolled 53 participants across 8 sites.

Detailed Summary

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with prostate-specific membrane antigen (PSMA)-negative biochemical recurrence of prostate cancer following definitive therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiochemical Recurrence of Malignant Neoplasm of Prostate
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJun 7, 2022
Enrollment StartSep 19, 2022
Primary CompletionMay 13, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.1 years ago

Interventions

64Cu-SAR-BBNdrug

64Cu-SAR-BBN