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.
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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+
References
Therapeutic Efficacy of a Bivalent Inhibitor of Prostate-Specific Membrane Antigen Labeled with 67Cu. [2022]Radionuclide therapy targeting prostate-specific membrane antigen (PSMA) is promising for prostate cancer. We previously reported a ligand, 64Cu-CuSarbisPSMA, featuring 2 lysine-ureido-glutamate groups. Here, we report the therapeutic potential of 67Cu-CuSarbisPSMA. Methods: Growth of PSMA-positive xenografts was evaluated after treatment with 67Cu-CuSarbisPSMA or 177Lu-LuPSMA imaging and therapy (I&T). Results: At 13 d after injection, tumor growth was similarly inhibited by the 2 tracers in a dose-dependent manner. Survival was comparable after single (30 MBq) or fractionated (2 × 15 MBq, 2 wk apart) administrations. Conclusion:67Cu-CuSarbisPSMA is efficacious in a PSMA-expressing model of prostate cancer.
Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer. [2021]Label="INTRODUCTION">The high diagnostic potential of 64Cu-PSMA PET-CT imaging was clinically investigated in prostate cancer patients with recurrent disease and in the primary staging of selected patients with advanced local disease. The aim of our study is to assess the uptake behavior in the clinical setting of 64Copper Prostate-Specific Membrane Antigen (64Cu PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) in prostate cancer.
64Cu-PSMA-BCH: a new radiotracer for delayed PET imaging of prostate cancer. [2021]Label="PURPOSE">Develop a 64Cu labeled radiopharmaceutical targeting prostate specific membrane antigen (PSMA) and investigate its application for prostate cancer imaging.
The Feasibility of 64Cu-PSMA I&T PET for Prostate Cancer. [2022]Background: The goal of this research was to investigate the feasibility of 64Cu labeling in prostate-specific membrane antigen imaging and therapy (PSMA I&T) for PSMA positron emission tomography (PET) imaging and biodistribution evaluation. Materials and Methods: PSMA I&T was labeled with 64Cu, and stability in human and mouse sera was evaluated. Prostate cancer cell lines were used for specific uptake assays (22RV1 for PSMA-positive, PC-3 for -negative). Both PC-3 and 22RV1 cells were transplanted into the left and right thighs in a mouse for PET/computed tomography (CT) imaging. Biodistribution was performed using 22RV1 tumor models. Results: Labeling yield (decay corrected) of 64Cu-PSMA I&T was more than 95% compared to the free 64Cu peak. The serum stability of 64Cu-PSMA I&T was maintained at more than 90% until 60 h. Regarding the specific binding of 64Cu-PSMA I&T was 7.5-fold higher to 22RV1 cells than PC-3 cells (p < 0.001). On PET/CT imaging, more specific 64Cu-PSMA I&T uptake was observed to 22RV1 tumors than to PC-3 tumors. In the PSMA blocking study using 2-phosphonomethoxypropyl adenine (2-PMPA), the 64Cu-PSMA I&T signal significantly decreased in the 22RV1 tumor region. In the biodistribution study, the kidney uptake was the highest among all organs at 2 h (52.6 ± 20.8%ID/g) but sharply decreased at 24 and 48 h. Also, the liver showed similar uptake over time (range, 10-12%ID/g). On the contrary, 64Cu-PSMA I&T uptake of the tumors increased with time and peaked at 48 h (5.6 ± 0.1%ID/g). Conclusions: PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging through in vitro and in vivo studies. Furthermore, 64Cu-PSMA I&T might be considered as the candidate of future clinical trial.
Dual-time-point 64 Cu-PSMA-617-PET/CT in patients suffering from prostate cancer. [2021]Regardless of its high positron energy, 68 Ga-labeled PSMA ligands have become standard of care in metabolic prostate cancer imaging. 64 Cu, a radionuclide with a much longer half-life (12.7 h), is available for PSMA labeling allowing imaging much later than 68 Ga. In this study, the diagnostic performance of 64 Cu-labeled PSMA was compared between early and late scans. Sixteen men (median age: 70 y) with prostate cancer in different stages underwent 64 Cu-PSMA-617-PET/CT 2 and 22 hours post tracer injection. Pathologic and physiologic uptakes were analyzed for both points of time. Pathologic tracer accumulations occurred in 12 patients. Five patients presented with pathologic uptake in 17 different lymph nodes, two patients showed pathologic bone uptake in nine lesions, and seven patients had pathologic PSMA uptake in eight prostatic lesions. Physiologic uptake of the renal parenchyma, urine bladder, and salivary glands decreased over time, while the physiologic uptake of liver and bowel increased. In the present study, 64 Cu-PSMA-617-PET demonstrated to be feasible for imaging prostate cancer for both the primary tumor site and metastases. Later imaging showed no additional, clinically relevant benefit compared with the early scans. At least the investigated time points we chose did not vindicate the additional expenditure.
Development of Novel PSMA Ligands for Imaging and Therapy with Copper Isotopes. [2020]Prostate-specific membrane antigen (PSMA)-binding tracers have been shown to be promising agents for the specific targeting of prostate tumors. On labeling with the short-lived isotopes 18F and 68Ga, excellent molecular imaging performance is achieved. This potential could be further exploited using long-lived isotopes. Because of the favorable half-life of 64Cu, tracers labeled with this PET nuclide could solve logistic problems. Moreover, this isotope provides a theranostic pair with the therapeutic copper isotope 67Cu. Hence, 9 novel tracers that combine dedicated copper chelators with the PSMA-specific urea-based binding motif were developed. Methods: The precursors were obtained by solid-phase synthesis. The purity and molecular weight of the PSMA ligands were confirmed by high-performance liquid chromatography and liquid chromatography-mass spectrometry. The compounds were labeled with 64Cu, with a radiolabeling yield of more than 99%. Competitive cell binding assays and internalization assays were performed with C4-2 cells, a subline of the PSMA-positive cell line LNCaP (human lymph node carcinoma of the prostate). In vitro serum stability, the stability of 64Cu-CA003 in blood, and the in vivo fate of neat 64Cu-chloride or 64Cu-CA003 were determined to prove whether the stability of the radiolabeled compounds is sufficient to ensure no significant loss of copper during the targeting process. For PET imaging and biodistribution studies, a C4-2 tumor-bearing mouse model was used. Results: The radiolabeled 64Cu-PSMA ligands showed high serum stability. All PSMA ligands showed high inhibition potencies, with equilibrium inhibition constants in the low nanomolar range. 64Cu-CA003 and 64Cu-CA005 showed high internalization ratios (34.6% ± 2.8 and 18.6% ± 4.4, respectively). Both the in vitro serum stability determination and the in vivo characterization of the main radiolabeled compounds confirmed that, except for 64Cu-PSMA-617, all compounds showed high serum stability within the observation period of 24 h. Small-animal PET imaging demonstrated high tumor uptake within 20 min. Organ distribution studies confirmed high specific uptake in the tumor, with 30.8 ± 12.6 percentage injected dose (%ID)/g at 1 h after injection. Rapid clearance from the kidneys was observed-a decrease from 67.0 ± 20.9 %ID/g at 1 h after injection to 7.5 ± 8.51 %ID/g at 24 h after injection (in the case of CA003). The performance of CA003, the compound with the best preclinical properties, was assessed in a first patient. In line with its preclinical data, PET imaging resulted in clear visualization of the cancer lesions, with high contrast. Conclusion: The 64Cu-labeled PSMA ligands are promising agents to target PSMA and visualize PSMA-positive tumor lesions as shown in preclinical evaluation by small-animal PET studies, organ distribution, and a patient application. Most importantly, the images obtained at 20 h enabled delineation of unclear lesions, showing that the compounds fulfill the prerequisite for dosimetry in the course of therapy planning with 67Cu. Thus, we suggest clinical use of copper-labeled CA003 for diagnostics and radiotherapy of prostate cancer.
Theranostic 64Cu-DOTHA2-PSMA allows low toxicity radioligand therapy in mice prostate cancer model. [2023]Label="Introduction" NlmCategory="UNASSIGNED">We have previously shown that copper-64 (64Cu)-DOTHA2-PSMA can be used for positron emission tomography (PET) imaging of prostate cancer. Owing to the long-lasting, high tumoral uptake of 64Cu-DOTHA2-PSMA, the objective of the current study was to evaluate the therapeutic potential of 64Cu-DOTHA2-PSMA in vivo.
Peptide and pseudo-peptide. [2021]In recent years, the introduction of theranostic twins for specific diagnosis and treatment in patients with neuroendocrine tumors became a nuclear medicine success story. 64Cu/18F labeled prostate specific membrane antigen (PSMA) for molecular imaging with PET-CT and peptide radioligand therapy with 177Lu labeled PSMA inhibitors will favorably become the next theranostic twins in nuclear medicine history. 68Ga/ 64Cu/18F PSMA PET/CT detects metastatic prostate cancer with high diagnostic sensitivity and specificity. In addition, it can be used to select patients for radioligand therapy and evaluate therapy response. 64Cu-labeled radiopharmaceuticals such as 64Cu-PSMA, and 64Cu-somatostatin analogs are promising imaging tools in the assessment of primary disease and also in the detection of disease recurrence and to evaluate therapy response. The long half-life of 64Cu allows the distribution of the tracer to PET centers as a satellite concept, who otherwise has no access to 68Ga generators.