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

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.

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 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. ^{1 2 3 4 5}

What data supports the effectiveness of the drug 64Cu-SAR-bisPSMA for prostate cancer?

Research shows that 67Cu-CuSarbisPSMA, a similar drug, effectively slows tumor growth in prostate cancer models. Additionally, 64Cu-PSMA imaging has been shown to be effective in detecting prostate cancer, suggesting potential for 64Cu-SAR-bisPSMA in treatment. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

Is 64Cu-SAR-bisPSMA safe for use in humans?

Research on 64Cu-SAR-bisPSMA and related compounds shows they have high stability in the body and are promising for imaging prostate cancer. Studies in mice and initial patient applications suggest they are safe, with no significant loss of copper during targeting, and they clear from the body effectively. ^{1 4 6 7 8}

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. ^{1 3 4 6 7}

How is the 64Cu-SAR-bisPSMA PET scan treatment different from other prostate cancer treatments?

The 64Cu-SAR-bisPSMA PET scan treatment is unique because it uses a copper-labeled compound to specifically target prostate-specific membrane antigen (PSMA) in prostate cancer cells, allowing for precise imaging and potential therapy. This approach benefits from the longer half-life of the copper isotope, which can improve imaging logistics and provide a theranostic (therapy and diagnostic) option when paired with therapeutic copper isotopes. ^{1 3 4 6 7}

Research Team

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Efficacy of a Bivalent Inhibitor of Prostate-Specific Membrane Antigen Labeled with 67Cu. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of prostate cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Dual-time-point 64 Cu-PSMA-617-PET/CT in patients suffering from prostate cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Development of Novel PSMA Ligands for Imaging and Therapy with Copper Isotopes. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Theranostic 64Cu-DOTHA2-PSMA allows low toxicity radioligand therapy in mice prostate cancer model. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

Peptide and pseudo-peptide. [2021]