64Cu-SAR-bisPSMA PET Scan for Prostate Cancer

(CLARIFY Trial)

Recruiting at 24 trial locations

Overseen By Clarity Pharmaceuticals

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Clarity Pharmaceuticals Ltd

Disqualifiers: Small cell, Neuroendocrine PC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

383 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new scan method to determine if prostate cancer has spread to nearby lymph nodes. It uses a special tracer called 64Cu-SAR-bisPSMA to help doctors identify potential cancer locations. The trial targets men diagnosed with untreated prostate cancer considered high-risk or worse. Participants should plan to undergo surgery to remove the prostate and some lymph nodes. The goal is to evaluate the effectiveness of this new scan in detecting cancer spread. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking diagnostic advancement.

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that 64Cu-SAR-bisPSMA is safe for use in PET scans?

Research has shown that 64Cu-SAR-bisPSMA is generally safe for humans. One study found it effectively detects prostate cancer and is well-tolerated by patients. In that study, patients reported no serious side effects and managed the treatment without major issues. Another study confirmed the safety of 64Cu-SAR-bisPSMA for detecting prostate cancer.

While side effects can occur with any treatment, current evidence suggests this one is quite safe. Prospective trial participants might find this information reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

64Cu-SAR-bisPSMA is unique because it uses a novel imaging agent, 64Cu-SAR-bisPSMA, that targets prostate-specific membrane antigen (PSMA) in prostate cancer cells. Unlike traditional imaging methods, this approach allows for more precise detection of cancerous cells. Researchers are excited about this treatment because it offers the potential for earlier and more accurate diagnosis, which can lead to better treatment planning and outcomes for patients with prostate cancer.

What evidence suggests that 64Cu-SAR-bisPSMA PET is effective for detecting prostate cancer metastases?

Research has shown that 64Cu-SAR-bisPSMA, the investigational treatment in this trial, effectively identifies prostate cancer that has spread to nearby lymph nodes. One study detected cancer in up to 80% of patients who had negative or unclear results with regular imaging tests. Additionally, tumors absorbed 64Cu-SAR-bisPSMA 2 to 3 times more than other methods, enhancing visibility. Another study found that this method led to changes in the treatment plan for nearly half of the patients, demonstrating its significant impact. Overall, 64Cu-SAR-bisPSMA shows promise for better identifying the spread of prostate cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Clarity Pharmaceuticals

Principal Investigator

Clarity Pharmaceuticals

Are You a Good Fit for This Trial?

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

You have provided a signed consent to participate.

My prostate cancer is considered high-risk based on its stage, grade, or PSA levels.

My prostate cancer has not been treated and is confirmed by a biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo 64Cu-SAR-bisPSMA PET scans to assess diagnostic performance for detecting regional nodal metastases

Up to 16 weeks

Multiple visits for PET scans

Follow-up

Participants are monitored for safety and effectiveness after diagnostic imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 64Cu-SAR-bisPSMA

Trial Overview

The 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.

How Is the Trial Designed?

Group I: 64Cu-SAR-bisPSMA Experimental Treatment 1 Intervention

200MBq 64Cu-SAR-bisPSMA.

Who Is Running the Clinical Trial?

Clarity Pharmaceuticals Ltd

Lead Sponsor

Trials

11

Recruited

720+

Published Research Related to This Trial

The study demonstrated that 64Cu labeling of PSMA I&T is highly effective, achieving over 95% labeling yield and maintaining over 90% stability in serum for up to 60 hours, making it a promising candidate for prostate cancer imaging.

In vivo tests showed that 64Cu-PSMA I&T specifically binds to prostate cancer cells (22RV1) significantly better than non-target cells (PC-3), with tumor uptake increasing over time, indicating its potential for effective PET imaging in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer. Lee, CH., Lim, I., Woo, SK., et al.[2022]

In a study involving 16 men with prostate cancer, 64 Cu-labeled PSMA-617-PET/CT imaging was found to be effective for detecting both primary tumors and metastases, demonstrating its feasibility for prostate cancer imaging.

However, comparing early (2 hours) and late (22 hours) scans revealed no significant clinical advantage of later imaging, suggesting that the additional time and resources may not be justified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual-time-point 64 Cu-PSMA-617-PET/CT in patients suffering from prostate cancer. Hoberück, S., Wunderlich, G., Michler, E., et al.[2021]

The 64Cu-PSMA-BCH radiopharmaceutical demonstrated high stability and specificity for prostate-specific membrane antigen (PSMA), showing significantly higher uptake in PSMA-positive cancer cells compared to PSMA-negative cells, which suggests its potential effectiveness for prostate cancer imaging.

In clinical applications, delayed imaging at 6 and 24 hours post-injection improved tumor detection rates, indicating that this radiopharmaceutical could enhance the accuracy of targeted biopsies in patients with suspected prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of prostate cancer. Liu, T., Liu, C., Zhang, Z., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peptide and pseudo-peptide. Mirzaei, S., Lipp, RW.[2021]

The novel 64Cu-labeled PSMA ligands demonstrated high serum stability and effective targeting of prostate tumors, with significant tumor uptake observed in preclinical studies, indicating their potential for accurate imaging and treatment.

In a patient application, the compound CA003 provided clear visualization of cancer lesions, supporting its use for diagnostics and therapy planning in prostate cancer, particularly in conjunction with the therapeutic isotope 67Cu.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 of 23 prostate cancer patients, 64Cu-PSMA PET-CT imaging effectively detected residual disease, with significant uptake observed in the prostate bed, lymph nodes, and distant metastases, highlighting its diagnostic potential.

The imaging showed increased tracer uptake over time, suggesting that 64Cu NODAGA-PSMA is stable and reliable for detecting prostate cancer progression, with a significant correlation between the number of positive uptake sites and pre-imaging PSA levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer. Sevcenco, S., Klingler, HC., Eredics, K., et al.[2021]

The study demonstrates that 67Cu-CuSarbisPSMA effectively inhibits tumor growth in prostate cancer models, showing similar efficacy to 177Lu-LuPSMA in a dose-dependent manner.

Both single and fractionated doses of 67Cu-CuSarbisPSMA resulted in comparable survival rates, indicating its potential as a viable therapeutic option for patients with PSMA-positive prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Efficacy of a Bivalent Inhibitor of Prostate-Specific Membrane Antigen Labeled with 67Cu. McInnes, LE., Cullinane, C., Roselt, PD., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1.

urotoday.com

urotoday.com/conference-highlights/asco-2025/asco-2025-prostate-cancer/161085-asco-2025-cobra-assessment-of-the-efficacy-of-64cu-sar-bispsma-using-histopathology-and-standard-of-care-imaging-as-reference-standard-in-patients-with-biochemical-recurrence-of-prostate-cancer-following-definitive-therapy.html

Assessment of the Efficacy of 64Cu-SAR-bisPSMA Using ...

Clinical evidence has shown that ⁶⁴Cu-SAR-bisPSMA achieves 2- to 3-fold higher tumor uptake on same-day imaging and enables detection of ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04868604

Study Details | NCT04868604 | 64Cu-SAR-bisPSMA and ...

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 ...

3.

claritypharmaceuticals.com

claritypharmaceuticals.com/news/cobra_results/

Initial COBRA results: Clarity's SAR-bisPSMA is safe and ...

Initial data from Clarity's diagnostic Phase 1/2 trial, COBRA, confirms 64Cu-SAR-bisPSMA is safe and highly effective in detecting prostate ...

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5100

Assessment of safety and efficacy of 64 Cu-SAR-bisPSMA ...

In patients with a negative or equivocal SOC scan, 64Cu-SAR-bisPSMA identified lesions in up to 80% of patients. More lesions and more patients ...

5.

onclive.com

onclive.com/view/64cu-sar-bispsma-bests-soc-68ga-psma-11-pet-ct-in-detecting-psma-positive-prostate-cancer-lesions

64Cu-SAR-bisPSMA Bests SOC 68Ga-PSMA-11 PET/CT ...

Findings from the trial revealed that 64Cu-SAR-bisPSMA led to a change in intended treatment plan in 48% of efficacy evaluable patients (n = 32) ...

6.

urotoday.com

urotoday.com/conference-highlights/snmmi-2024/152784-snmmi-2024-cobra-assessment-of-safety-and-efficacy-of-64cu-sar-bispsma-in-patients-with-biochemical-recurrence-of-prostate-cancer-following-definitive-therapy.html

Assessment of Safety and Efficacy of 64Cu-SAR-bisPSMA ...

The COBRA study was a phase I/II study assessing the safety and efficacy of 64 Cu-SAR-bisPSMA (200 MBq) in prostate cancer patients with biochemical recurrence.

7.

cancernetwork.com

cancernetwork.com/view/64cu-sar-bispsma-pet-detects-more-prostate-cancer-lesions-vs-soc

64Cu-SAR-bisPSMA PET Detects More Prostate Cancer ...

The novel PET imaging agent detected significantly more PSMA-positive prostate cancer lesions vs SOC in patients with low PSA levels.

8.

claritypharmaceuticals.com

claritypharmaceuticals.com/news/ftd-2/

Clarity receives U.S. FDA Fast Track Designation for Cu ...

We have seen 2-3 times higher uptake in prostate cancer lesions and the identification of more lesions using 64Cu-SAR-bisPSMA compared to 68Ga- ...