Cu-SAR-bisPSMA for Prostate Cancer

(SECuRE Trial)

Recruiting at 10 trial locations

Overseen By Clarity Pharmaceuticals

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Clarity Pharmaceuticals Ltd

Must be taking: Androgen deprivation therapy

Must not be taking: Systemic radionuclides, Chemotherapy

Disqualifiers: Brain metastasis, Leukemia, others

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

Compensation: Varies

Number of Visits: 1

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 67Cu-SAR-bisPSMA, a type of targeted radiotherapy, to determine its safety and effectiveness for individuals with prostate cancer that no longer responds to standard hormone therapy. The treatment targets a protein called PSMA, found in high amounts in certain prostate cancers. It is intended for those with advanced prostate cancer that continues to spread despite previous hormone therapies. Participants must have a confirmed diagnosis of this prostate cancer and show signs of disease progression, such as rising PSA levels or new cancer growths. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain cancer treatments, you may need to stop them a few weeks before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that 67Cu-SAR-bisPSMA is safe for treating prostate cancer. In earlier studies, patients tolerated the treatment well, and no major safety issues emerged as the dose increased to determine the optimal amount. This indicates that the treatment is manageable and does not cause severe side effects. The FDA has granted 67Cu-SAR-bisPSMA fast track status, acknowledging its potential to meet an important medical need. Although research continues, early results support its safety for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about 67Cu-SAR-bisPSMA because it offers a novel approach to treating prostate cancer by using a targeted radioisotope. Unlike standard treatments such as hormone therapy or chemotherapy, this treatment specifically targets the PSMA protein, which is often overexpressed in prostate cancer cells. The use of the radioisotope Copper-67 allows the treatment to deliver radiation directly to the cancer cells, potentially reducing damage to healthy tissues and improving precision. This targeted mechanism could lead to better outcomes and fewer side effects for patients, making it a promising option in the fight against prostate cancer.

What evidence suggests that 67Cu-SAR-bisPSMA might be an effective treatment for prostate cancer?

Research has shown that a compound similar to 67Cu-SAR-bisPSMA, called 64Cu-SAR-bisPSMA, delivers promising results in treating prostate cancer. In some studies, 64Cu-SAR-bisPSMA was 2 to 3 times more effective at reaching cancer cells, targeting them more precisely. It also detected abnormal tissue in up to 80% of patients who did not have clear results with standard scans. This suggests that the treatment could excel in finding and treating prostate cancer. In this trial, participants will receive either 64Cu-SAR-bisPSMA or 67Cu-SAR-bisPSMA. Additionally, the FDA has fast-tracked 67Cu-SAR-bisPSMA, highlighting its potential as a promising treatment for prostate cancer that does not respond to hormone therapy. ^{2 6 7 8 9}

Who Is on the Research Team?

Clarity Pharmaceuticals

Principal Investigator

Clarity Pharmaceuticals

Are You a Good Fit for This Trial?

Men over 18 with metastatic castrate resistant prostate cancer that's gotten worse despite treatment, and who have a certain level of organ function. They must not have brain metastases, small cell or neuroendocrine prostate cancer, recent major surgery, or other serious health issues. Participants need to use birth control if applicable.

Inclusion Criteria

My testosterone levels are very low.

My PET/CT scan shows a lesion with higher activity than my liver.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I haven't had certain radioactive treatments in the last 3-6 months.

I have a severe blockage in my urinary tract that can't be easily treated.

I have not received a transfusion just to qualify for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry Phase

Participants receive a single 200 MBq administration of 64Cu-SAR-bisPSMA to assess dosimetry

1 week

1 visit (in-person)

Dose Escalation Phase

Participants receive up to 2 administrations of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA to determine the recommended dose

8 weeks

Multiple visits (in-person)

Cohort Expansion Phase

Participants receive up to 3 administrations of 64Cu-SAR-bisPSMA and 2 administrations of 67Cu-SAR-bisPSMA at the recommended dose

14 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• 64Cu-SAR-bisPSMA
• 67Cu-SAR-bisPSMA

Trial Overview The trial is testing the safety and effectiveness of two radioactive drugs called 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA in targeting and treating advanced prostate cancer that shows up on special PET/CT scans.

How Is the Trial Designed?

Group I: 67Cu-SAR-bisPSMA Experimental Treatment 2 Interventions

In the dosimetry phase patients will receive a single 200 MBq administration of 64Cu-SAR-bisPSMA. In the dose escalation phase patients will receive up to 2 administrations of 200 MBq of 64Cu-SAR-bisPSMA. In the cohort expansion phase patients will receive up to 3 administrations of 200 MBq of 64Cu-SAR-bisPSMA. In the dose escalation phase patients will receive up to 4 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation). In the cohort expansion phase patients will receive 4 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation.

Who Is Running the Clinical Trial?

Clarity Pharmaceuticals Ltd

Lead Sponsor

Trials

11

Recruited

720+

Published Research Related to This Trial

In a study of 125 men with metastatic castrate-resistant prostate cancer treated with 177LuPSMA, personalizing treatment intervals based on early response biomarkers (PSA and SPECT imaging) led to improved progression-free survival (PFS) and overall survival (OS), with a median OS of 16.8 months overall.

The study found that 35% of patients could take treatment breaks after showing a marked response, resulting in a median PFS of 12.1 months for this group, compared to shorter PFS for those with less favorable responses, highlighting the potential for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient outcomes following a response biomarker-guided approach to treatment using 177Lu-PSMA-I&T in men with metastatic castrate-resistant prostate cancer (Re-SPECT). Emmett, L., John, N., Pathmanandavel, S., et al.[2023]

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]

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]

The radiolabeled ligand [64Cu]PSMA-617 demonstrated high radiochemical purity (>99%) and specific uptake in prostate cancer cells, indicating its potential for effective PET imaging of prostate cancer.

In vivo studies showed that [64Cu]PSMA-617 successfully visualized tumor areas in mice, although it exhibited slow clearance from the kidneys and high uptake in the liver, suggesting that modifications to its structure could enhance its use in imaging and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and evaluation of [64Cu]PSMA-617 targeted for prostate-specific membrane antigen in prostate cancer. Cui, C., Hanyu, M., Hatori, A., et al.[2020]

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]

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]

Treatment with lutetium-177 (177Lu)-prostate-specific membrane antigen (PSMA) significantly reduces prostate-specific antigen (PSA) levels in patients with advanced metastatic prostate cancer, especially after the first treatment cycle.

The therapy shows a beneficial effect on reducing lymph node metastasis, while also indicating potential negative impacts on visceral metastasis, highlighting its efficacy in managing certain aspects of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Advanced Metastatic Prostate Cancer Using Molecular-Targeted Therapy: Radioligand Lutetium-177 Prostate-Specific Membrane Antigen. Rathore, R., Rangrej, SB., Kieme, I., et al.[2023]

Copper-64 (64Cu) is being explored as a promising alternative to existing radiopharmaceuticals like gallium-68 and lutetium-177 for targeting neuroendocrine tumors and prostate cancer due to its unique nuclear properties that allow for both imaging and therapeutic effects.

64Cu can specifically target cancerous cells and may help detect early metastatic processes, leveraging its biological role in cellular functions, which enhances its potential as a theranostic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging value of 64Cu for molecular imaging and therapy. Bolzati, C., Duatti, A.[2021]

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. 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 ...

4. claritypharmaceuticals.com claritypharmaceuticals.com/news/ftd-67cu-sarbispsma/

Clarity receives US FDA Fast Track Designation ... Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA.

5. targetedonc.com targetedonc.com/view/fda-grants-fast-track-designation-to-67cu-sar-bispsma-in-mcrpc

FDA Grants Fast Track Designation to 67Cu-SAR- ... The FDA has granted fast track status to 67Cu-SAR-bisPSMA for metastatic prostate cancer that is resistant to hormone therapy after prior treatment.

6. claritypharmaceuticals.com claritypharmaceuticals.com/wp-content/uploads/2024/07/SNMMI-2024-SECuRE1-Final.pdf

67Cu-SAR-bisPSMA in patients with metastatic castrate- ... This study is being conducted in 3 phases: a 64Cu-SAR-. bisPSMA Dosimetry Phase (n=6), a 67Cu-SAR-bisPSMA Dose Escalation Phase (n=up to 24), and a 67Cu-SAR- ...

7. targetedonc.com targetedonc.com/view/secure-trial-highlights-safety-efficacy-of-67cu-sar-bispsma-in-mcrpc

SECuRE Trial Highlights Safety, Efficacy of 67Cu-SAR- ... The dose-escalation phase of the SECuRE trial in prostate cancer has completed and demonstrated promising safety and efficacy data.

8. urologytimes.com urologytimes.com/view/dose-expansion-begins-in-phase-1-2-trial-of-67cu-sar-bispsma-in-mcrpc

Dose expansion begins in phase 1/2 trial of 67Cu-SAR- ... The SECuRE trial is assessing 67Cu-SAR-bisPSMA in mCRPC, focusing on pre-chemotherapy settings and combination therapy with enzalutamide.

9. cancernetwork.com cancernetwork.com/view/cu-67-sar-bispsma-granted-fast-track-designation-for-metastatic-crpc

Cu-67 SAR-bisPSMA Granted Fast Track Designation for ... The FDA has granted 67 Cu-SAR-bisPSMA fast track designation for the treatment of adult patients with prostate-specific membrane antigen (PSMA)–positive ...