Copper PET Imaging for Prostate Cancer (Solar-Stage Trial)
Palo Alto (17 mi)Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Curium US LLC
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
What safety data exists for Copper PET Imaging in prostate cancer?The safety data for Copper PET Imaging, specifically using Copper Cu 64 PSMA I&T, is primarily derived from preclinical studies. These studies have shown high radiolabeling efficiency and stability in serum, with specific uptake in PSMA-positive prostate cancer cells and tumors. Biodistribution studies in mice indicated high initial uptake in the kidneys and liver, with tumor uptake increasing over time. The imaging has demonstrated high spatial resolution and the ability to visualize PSMA-positive tumors effectively. While these results are promising, they are mostly preclinical, and further clinical trials are needed to fully establish safety and efficacy in humans.12456
What data supports the idea that Copper PET Imaging for Prostate Cancer is an effective treatment?The available research shows that Copper PET Imaging, specifically using 64Cu-PSMA, is effective in detecting prostate cancer. It has a high ability to identify cancerous areas, including the primary tumor and any spread to other parts of the body. This imaging method provides clear pictures, which helps doctors see small cancer spots better than some other imaging techniques. The studies also suggest that Copper PET Imaging can be used later than other similar methods, giving doctors more flexibility in timing. Overall, it is a promising tool for diagnosing and managing prostate cancer.23578
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop your current medications. However, you cannot have had androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy, or any investigational therapy for prostate cancer before the prostatectomy. It's best to discuss your current medications with the trial team.
Is the drug Copper Cu 64 PSMA I&T a promising treatment for prostate cancer?Yes, Copper Cu 64 PSMA I&T is a promising drug for prostate cancer. It helps doctors see cancer clearly using special imaging, which can lead to better diagnosis and treatment planning. It shows high accuracy in detecting prostate cancer and can be used for both imaging and therapy, making it a valuable tool in managing the disease.24568
Eligibility Criteria
Men over 18 with newly diagnosed, high-risk prostate cancer who are planning to undergo prostatectomy and lymph node dissection. They must have a confirmed diagnosis of prostate adenocarcinoma and understand the study enough to give informed consent.Inclusion Criteria
I am a man aged 18 or older.
I am scheduled for prostate surgery with lymph node removal.
I have been diagnosed with prostate cancer through a biopsy.
My condition is classified as intermediate to very high risk according to NCCN guidelines.
Exclusion Criteria
I haven't had high-energy radiation treatment recently.
I have not had hormone therapy, chemotherapy, radiation, or experimental treatments for prostate cancer before surgery.
I am not scheduled for an x-ray contrast or PET radiotracer before my PET scan.
Treatment Details
The trial is testing Copper Cu 64 PSMA I&T injection for PET/CT imaging in men with new, unfavorable intermediate to very high-risk prostate cancer. It's an open-label Phase 3 study, meaning everyone knows what treatment they're getting.
1Treatment groups
Experimental Treatment
Group I: Diagnostic Imaging with Copper Cu 64 PSMA I&TExperimental Treatment1 Intervention
Copper Cu 64 PSMA I\&T Injection
Find a clinic near you
Research locations nearbySelect from list below to view details:
XCancerOmaha, NE
Adaptive Research Inc.Hawthorne, NY
CIRA HealthMiami, FL
Queens Hospital CenterJamaica, NY
More Trial Locations
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Who is running the clinical trial?
Curium US LLCLead Sponsor
References
Synthesis and evaluation of [64Cu]PSMA-617 targeted for prostate-specific membrane antigen in prostate cancer. [2020]We radiolabeled a ligand, PSMA-617, of prostate-specific membrane antigen (PSMA) with copper-64 (64Cu), to evaluate the metabolism, biodistribution, and potential of [64Cu]PSMA-617 for PET imaging of prostate cancer. [64Cu]PSMA-617 was synthesized by heating PSMA-617 with [64Cu]CuCl2 in buffer solution at 90°C for 5 min. In vitro uptake was determined in two cell lines of prostate cancer. In vivo regional distributions were determined in normal and tumor-bearing mice. High radiolabeling efficiency of 64Cu for PSMA-617 yielded [64Cu]PSMA-617 with >99% radiochemical purity. In vitro cellular uptake experiments demonstrated the specificity of [64Cu]PSMA-617 for PSMA-positive LNCaP cells. Biodistribution observations of normal mice revealed high uptake of radioactivity in the kidney and liver. PET with [64Cu]PSMA-617 visualized tumor areas implanted by PSMA-positive LNCaP cells in the mice. Two hours after the injection of [64Cu]PSMA-617 into mice, a radiolabeled metabolite was observed in the blood, liver, urine, and LNCaP tumor tissues. [64Cu]PSMA-617 was easily synthesized, and exhibited a favorable biodistribution in PSMA-positive tumors. Although this radioligand shows slow clearance for kidney and high liver uptake, change of its chelator moiety and easy radiolabeling may enable development of new 64Cu or 67Cu-labeled PSMA ligands for imaging and radiotherapy.
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.
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.
Copper, PET/CT and prostate cancer: a systematic review of the literature. [2023]Copper is an essential element that plays an important role in both cancer development and growth. Indeed, high levels of copper have been found in prostate cancer (PCa), and this finding have paved the way for the use of this element as a target for positron emission tomography (PET) imaging. Copper64 (64Cu) can be used alone, as 64CuCl<inf>2</inf>, and also as a precursor for the in-vitro radio-labelling of specific carriers for PET imaging in PCa, (e.g. associated to prostate-specific membrane antigen: PSMA). The use of 64Cu-PSMA can yield late acquisitions in which PET images are characterized by a higher target-to-background ratio. At the same time, the shorter positron range of 64Cu provides high spatial resolution, which leads to better detection of small lesions. In this context, the aim of this review was to systematically review studies evaluating the identification of PCa in humans by means of 64CuCl<inf>2</inf> and other PET tracers radio-labelled with 64Cu.
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.
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.
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.