~117 spots leftby Dec 2025

64Cu-SAR-bisPSMA PET Scan for Prostate Cancer

(CLARIFY Trial)

Recruiting in Palo Alto (17 mi)
+21 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Clarity Pharmaceuticals Ltd
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking any high energy gamma-emitting radioisotopes, you must stop them at least 5 half-lives before the trial starts.

What data supports the idea that 64Cu-SAR-bisPSMA PET Scan for Prostate Cancer is an effective treatment?

The available research shows that 64Cu-SAR-bisPSMA is effective in detecting prostate cancer. One study found that it successfully identified cancer in different stages, including in lymph nodes and bones. Another study demonstrated that 64Cu-SAR-bisPSMA had a high level of accuracy in imaging prostate cancer, making it a promising option for diagnosing the disease. Additionally, it was shown to be stable and effective in targeting cancer cells in both lab and animal studies. Compared to other imaging methods, 64Cu-SAR-bisPSMA allows for later imaging, which can be beneficial for detailed diagnosis.12345

What safety data exists for 64Cu-SAR-bisPSMA PET Scan for Prostate Cancer?

The safety data for 64Cu-SAR-bisPSMA and related compounds indicate high serum stability and specific tumor uptake, with rapid clearance from non-target organs like the kidneys. Studies have shown that 64Cu-labeled PSMA ligands are promising for targeting and visualizing PSMA-positive tumors, with high contrast in imaging and potential for therapy planning. The compounds have demonstrated low toxicity in preclinical models, suggesting they are safe for further clinical evaluation.14678

Is the 64Cu-SAR-bisPSMA PET scan a promising treatment for prostate cancer?

Yes, the 64Cu-SAR-bisPSMA PET scan is a promising treatment for prostate cancer. It uses a special tracer that targets prostate cancer cells, allowing doctors to see the cancer clearly in scans. This helps in planning effective treatments and can also be used for therapy, making it a valuable tool in managing prostate cancer.13467

Research Team

CP

Clarity Pharmaceuticals

Principal Investigator

Clarity Pharmaceuticals

Eligibility Criteria

This trial is for men at least 18 years old with high-risk prostate cancer, as defined by specific clinical stages, grade groups, or PSA levels. Participants must be planning to undergo radical prostatectomy with lymph node dissection and have not received prior treatment for their confirmed adenocarcinoma of the prostate.

Inclusion Criteria

I am 18 years old or older.
You have provided a signed consent to participate.
My prostate cancer is considered high-risk based on its stage, grade, or PSA levels.
See 2 more

Treatment Details

Interventions

  • 64Cu-SAR-bisPSMA (Cancer Imaging Agent)
Trial OverviewThe study is testing a diagnostic procedure using a PET scan with a tracer called 64Cu-SAR-bisPSMA. The goal is to see how well this method can identify if the cancer has spread to regional lymph nodes in patients scheduled for surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 64Cu-SAR-bisPSMAExperimental Treatment1 Intervention
200MBq 64Cu-SAR-bisPSMA.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
The Urology PlaceSan Antonio, TX
Mayo Clinic- PhoenixPhoenix, AZ
Mayo Clinic- JacksonvilleJacksonville, FL
Mayo Clinic- RochesterRochester, MN
More Trial Locations
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Who Is Running the Clinical Trial?

Clarity Pharmaceuticals Ltd

Lead Sponsor

Trials
11
Patients Recruited
720+

Findings from Research

Therapeutic Efficacy of a Bivalent Inhibitor of Prostate-Specific Membrane Antigen Labeled with 67Cu.McInnes, LE., Cullinane, C., Roselt, PD., et al.[2022]
Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer.Sevcenco, S., Klingler, HC., Eredics, K., et al.[2021]
64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of prostate cancer.Liu, T., Liu, C., Zhang, Z., et al.[2021]
The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer.Lee, CH., Lim, I., Woo, SK., et al.[2022]
Dual-time-point 64 Cu-PSMA-617-PET/CT in patients suffering from prostate cancer.Hoberück, S., Wunderlich, G., Michler, E., et al.[2021]
Development of Novel PSMA Ligands for Imaging and Therapy with Copper Isotopes.Carlos Dos Santos, J., Beijer, B., Bauder-Wüst, U., et al.[2020]
In a study involving LNCaP tumor-bearing mice, treatment with 64Cu-DOTHA2-PSMA significantly improved survival compared to the control group receiving natCu-DOTHA2-PSMA, indicating its potential as an effective therapeutic option for prostate cancer.
The treatment with 64Cu-DOTHA2-PSMA showed acceptable safety, with normal red blood cell counts and no significant signs of radiation injury, although there was some concern regarding hepatic and gastrointestinal irradiation.
Theranostic 64Cu-DOTHA2-PSMA allows low toxicity radioligand therapy in mice prostate cancer model.Milot, MC., Bélissant-Benesty, O., Dumulon-Perreault, V., et al.[2023]
The use of 64Cu/18F labeled prostate specific membrane antigen (PSMA) for PET-CT imaging and 177Lu labeled PSMA inhibitors for therapy represents a significant advancement in the diagnosis and treatment of neuroendocrine tumors, particularly metastatic prostate cancer.
64Cu-labeled radiopharmaceuticals provide high diagnostic sensitivity and specificity for detecting metastatic prostate cancer, and their longer half-life allows for broader distribution to PET centers, enhancing access to advanced imaging and therapy options.
Peptide and pseudo-peptide.Mirzaei, S., Lipp, RW.[2021]

References

Therapeutic Efficacy of a Bivalent Inhibitor of Prostate-Specific Membrane Antigen Labeled with 67Cu. [2022]
Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer. [2021]
64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of prostate cancer. [2021]
The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer. [2022]
Dual-time-point 64 Cu-PSMA-617-PET/CT in patients suffering from prostate cancer. [2021]
Development of Novel PSMA Ligands for Imaging and Therapy with Copper Isotopes. [2020]
Theranostic 64Cu-DOTHA2-PSMA allows low toxicity radioligand therapy in mice prostate cancer model. [2023]
Peptide and pseudo-peptide. [2021]