Nanoparticles for Prostate Cancer

Recruiting at 1 trial location

Overseen By Karim Touijer, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Metal implants, Claustrophobia, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: 2

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help surgeons locate prostate cancer cells during surgery. Researchers use a special tracer, called (64Cu)-labeled PSMA-targeting particle tracer, which illuminates cancer cells on scans, making them easier to identify. This marks the first time this tracer is tested in prostate cancer surgery. Men with prostate cancer scheduled for surgery and with aggressive disease (such as a high Gleason score or high PSA level) might be suitable candidates for this trial. 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 innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have certain medical conditions like uncontrolled infections or heart issues, you may not be eligible to participate.

What prior data suggests that this method is safe for identifying tumor cells in prostate cancer patients?

Research has shown that the special nanoparticles used in this trial are generally safe in early animal tests. These nanoparticles assist doctors in identifying prostate cancer cells during imaging and have been well-tolerated in these studies. No major safety issues have been reported so far.

In this trial, researchers are using these nanoparticles for the first time in patients undergoing prostate cancer surgery. As this is an early stage of testing, the primary goal is to assess safety, with the treatment closely monitored for any side effects. This step is crucial to understanding how the treatment functions in the human body and ensuring its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for prostate cancer, which typically includes surgery, radiation, and hormone therapy, the (64Cu)-labeled PSMA-targeting particle tracer offers a new way to visualize and treat the disease. This treatment is unique because it uses nanoparticles to target PSMA, a protein found on the surface of prostate cancer cells. By labeling these particles with copper-64, a radioactive isotope, doctors can use PET/MR imaging to precisely track the tracer within the body, providing a detailed map of the cancer's spread. Researchers are excited about the potential for this technique to improve the accuracy of cancer detection and to guide more effective treatment plans, all while offering insights into the safety and behavior of the tracer in the body.

What evidence suggests that this tracer is effective for identifying prostate cancer?

Research shows that the 64Cu-labeled PSMA-targeting tracer, which participants in this trial will receive, attaches specifically to a protein called PSMA on prostate cancer cells. This targeted approach aids in accurately identifying cancerous areas. Early studies indicate that this tracer effectively highlights tumor cells during imaging, potentially improving detection and treatment planning for prostate cancer. The tracer pinpoints cancerous spots more precisely than standard imaging methods. This technique aims to offer clearer insights during surgery for prostate cancer patients. ^{1 2 4 6 7}

Who Is on the Research Team?

Karim Touijer, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Men over 18 with prostate cancer who are fit for surgery and scheduled for a specific type of operation to remove the prostate or salvage lymph node dissection. They must have certain tumor characteristics like size, shape, or PSA levels. Excluded are those with prior pelvic radiotherapy (except for some cases), weight over 400 lbs, severe claustrophobia, metal implants incompatible with MRI, recent heart issues, kidney problems or uncontrolled infections.

Inclusion Criteria

My doctor thinks I am healthy enough for surgery.

My prostate cancer is advanced, has a high Gleason score, or my PSA level is over 20.

I am scheduled for a laparoscopic prostate surgery.

Exclusion Criteria

Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)

I cannot stay still in a scanner for 30 minutes.

I have undergone hormone therapy for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Imaging

Participants receive an intravenous injection of the PSMA-targeting C' dot tracer and undergo serial preoperative PET/MR imaging

Up to 48 hours

1 visit (in-person)

Surgery

Participants undergo surgery for prostate cancer with guidance from imaging results

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including side effects described using CTCAE version 5 criteria

1 year

What Are the Treatments Tested in This Trial?

Interventions

• (64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots

Trial Overview The trial is testing a new tracer called 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots during surgery to see if it's better at finding cancer cells than current imaging methods. Participants will undergo PET/MRI scans after receiving this experimental tracer to track its distribution in the body.

How Is the Trial Designed?

Group I: Prostate cancer patients Experimental Treatment 4 Interventions

Patients will receive an intravenous (IV) injection of approximately 6-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer up to 48 hours before surgery. Patients will then undergo serial preoperative PET/MR imaging to help characterize the safety, biodistribution/pharmacokinetics, and dosimetry of this agent. To assess total radioactivity in whole blood/plasma and urine samples, as well as radioactive metabolites, blood and urine samples will be collected at approximately 30 min post-injection as well as before each imaging session

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Cornell University/Weill Cornell Medical Center

Collaborator

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Elucida Oncology

Industry Sponsor

Trials

3

Recruited

90+

Published Research Related to This Trial

In a study of 24 patients with primary prostate cancer, Ga-PSMA-11 PET/CT demonstrated a high detection rate of 95.8%, confirming its effectiveness in identifying cancerous lesions.

Dynamic PET/CT imaging showed that Ga-PSMA-11 accumulation in prostate cancer lesions increased over time, suggesting its potential for enhancing treatment strategies targeting PSMA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 Dynamic PET/CT Imaging in Primary Prostate Cancer. Sachpekidis, C., Kopka, K., Eder, M., et al.[2022]

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 study developed a series of 68Ga/177Lu-labeled PSMA tracers with PEGylation that significantly improved tumor accumulation and reduced kidney retention, enhancing their effectiveness for diagnosing and treating prostate cancer.

Among the tested probes, [68Ga]Ga-DOTA-(2P-PEG4)2 showed superior tumor-targeting ability and prolonged retention in tumor tissues, making it a promising candidate for future clinical applications in prostate cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imageological/Structural Study regarding the Improved Pharmacokinetics by 68Ga-Labeled PEGylated PSMA Multimer in Prostate Cancer. Zhang, H., Rao, M., Zhao, H., et al.[2023]

RPS-085 is a newly developed ligand that effectively targets prostate-specific membrane antigen (PSMA) and shows strong potential for both imaging and treating prostate cancer, with an IC50 of 29 nM indicating its potency as a PSMA inhibitor.

The compound demonstrates favorable pharmacokinetics, with rapid clearance from kidneys and prolonged retention in tumors, suggesting a high therapeutic index for prostate cancer treatment using the radionuclide pair [64/67Cu].

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Evaluation of a High-Affinity Sarcophagine-Containing PSMA Ligand for 64Cu/67Cu-Based Theranostics in Prostate Cancer. Kelly, JM., Ponnala, S., Amor-Coarasa, A., 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]

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 64Cu-labeled PSMA tracer, 64Cu-PSMA-CM, shows improved tumor detection capabilities due to its high binding affinity to human serum albumin, which prolongs its half-life in the bloodstream and enhances tumor accumulation.

In comparison to another tracer, 64Cu-PSMA-BCH, 64Cu-PSMA-CM demonstrated significantly higher and prolonged accumulation in PSMA-overexpressing tumors, indicating its potential effectiveness for targeted prostate cancer diagnosis and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Albumin-Binding PSMA Ligand with Higher Tumor Accumulation for PET Imaging of Prostate Cancer. Ren, Y., Liu, T., Liu, C., et al.[2022]

The newly developed 18F-labeled PSMA-targeting agents, particularly 18F-PEG3-VS-PSMAi, demonstrated significantly higher tumor uptake compared to the FDA-approved 68Ga-PSMA-11, with nearly double the uptake in animal models.

These agents also showed favorable tumor-to-liver ratios, indicating their potential for improved imaging contrast in prostate cancer, suggesting they are promising candidates for further evaluation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of 18F-Labeled Vinyl Sulfone-PSMAi Conjugates as New PET Agents for Prostate Cancer Imaging. Zhang, T., Cai, J., Xu, M., et al.[2022]

The study developed prostate cancer-targeting starPEG nanocarriers that significantly improved tumor retention and deep tissue penetration compared to nontargeted versions, demonstrating the effectiveness of using prostate-specific membrane antigen (PSMA) targeting.

Multivalent ACUPA ligands on the nanocarriers enhanced binding affinity to prostate cancer cells, leading to better pharmacokinetics and lower retention in healthy tissues, suggesting a promising strategy for improving drug delivery in prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate-Specific Membrane Antigen Targeted Deep Tumor Penetration of Polymer Nanocarriers. Meher, N., Ashley, GW., Bidkar, AP., et al.[2023]

Citations

1. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/copper-cu-64-nota-psmai-peg-cy55-c-dots

Definition of copper Cu 64 NOTA-PSMAi-PEG-Cy5.5-C' dots Upon administration of the copper Cu 64 NOTA-PSMAi-PEG-Cy5.5-C' dots, the PSMAi moiety selectively targets and binds to PSMA expressed on tumor cells. Upon PET ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04167969

Study Details | NCT04167969 | The Use of Nanoparticles ... The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi- ...

3. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/copper-cu-64-nota-psmai-peg-cy55-c-dots

Clinical Trials Using Copper Cu 64 NOTA-PSMAi-PEG-Cy5 ... NCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying copper cu 64 nota-psmai-peg-cy5.5-c' dots.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3983358/

64Cu-Labeled Inhibitors of Prostate-Specific Membrane ... Prostate-specific membrane antigen (PSMA) is a well-recognized target for identification and therapy of a variety of cancers.

5. researchgate.net researchgate.net/publication/396454458_Preclinical_evaluation_and_dosimetry_of_64Cu67CuCu-NGUL_for_PSMA-targeted_prostate_cancer_theranostics

Preclinical evaluation and dosimetry of [64Cu/67Cu]Cu ... Purpose Prostate-specific membrane antigen (PSMA) is an attractive target for radionuclide therapy of metastatic castration-resistant prostate ...

6. withpower.com withpower.com/trial/phase-1-prostatic-neoplasms-10-2019-39b93

Nanoparticles for Prostate Cancer The studies on 64Cu-labeled PSMA-targeting nanoparticles, used for imaging prostate cancer, show that they are generally safe in preclinical models, with high ...

7. theranostictrials.org theranostictrials.org/studies/clsupindl001l11ujhnhud8tu/study/NCT04167969

NCT04167969 The purpose of this study is to see whether using the 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer is a safe way to identify tumor cells before and during surgery ...