What is the mechanism of action of this treatment?

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to prevent cancer growth, and chemotherapy, which targets rapidly dividing cells. Radiopharmaceuticals like Lutetium-177-PSMA target prostate-specific membrane antigens to deliver radiation directly to cancer cells. The IS-002 trial involves a fluorescent agent used during surgery to visualize cancerous tissues, enhancing precision in tumor removal. These mechanisms are crucial as they offer targeted approaches to manage and treat prostate cancer, potentially improving outcomes and reducing side effects for patients.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as radioligand therapy (e.g., 177Lu-PSMA), chemotherapy (e.g., docetaxel, cabazitaxel), and immunotherapy (e.g., sipuleucel-T), have a range of side effects. Radioligand therapy often causes myelosuppression, nephrotoxicity, and salivary gland toxicity (pain, swelling, dry mouth). Chemotherapy can lead to anemia, fatigue, nausea, and increased risk of infections. Immunotherapy side effects include flu-like symptoms, fatigue, and potential for autoimmune reactions. These side effects are important considerations when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including androgen receptor-targeted therapies like enzalutamide and abiraterone, which are used in metastatic castration-resistant prostate cancer (mCRPC). Additionally, radioligand therapies such as lutetium Lu 177 vipivotide tetraxetan have been approved for PSMA-positive mCRPC. While specific fluorescent agents for cancer visualization in prostate cancer are not mentioned, the use of advanced imaging techniques and radioligand therapies highlights the ongoing efforts to improve cancer detection and treatment efficacy.

What other types of research exist?

Promising alternatives to IS-002 for prostate cancer visualization include: 1) A11 cMb, a dual-labeled humanized anti-PSCA cys-minibody for immunoPET/fluorescence imaging, which targets prostate stem cell antigen (PSCA). 2) QD-RGD-BBN, a functionalized quantum dot for dual-modality PET/NIRF imaging, which targets prostate tumors. 3) PSMA-I&F, a PSMA-targeted hybrid tracer for nuclear and fluorescence imaging, which targets prostate-specific membrane antigen (PSMA).

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Firefly Fluorescent Imaging + IS-002 for Prostate Cancer

Phase 2

Recruiting

Research Sponsored by Intuitive Surgical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-surgery

Summary

This trial tests a new method using IS-002 and special imaging to help surgeons see prostate cancer better during robotic surgery. It aims to improve the accuracy of cancer removal in patients undergoing this procedure.

Who is the study for?

Men aged 18-75 with confirmed prostate cancer, willing to undergo surgery using a specific robotic system. They must have a high risk of aggressive disease based on certain clinical criteria and be able to follow study procedures. Men who've had recent investigational therapies, liver or kidney diseases, or treatments like hormone therapy in the last 4 months can't join.

What is being tested?

The trial is testing IS-002 alongside near-infrared imaging during robotic-assisted surgery for prostate cancer. It aims to improve tumor identification and removal accuracy using the da Vinci Surgical System equipped with Firefly Fluorescence Imaging.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical surgical risks such as bleeding, infection, and reactions related to IS-002 which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.

The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.

Secondary study objectives

Diagnostic performance of IS-002 fluorescence

Number of intraoperative fluorescent lymph nodes that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only

Pharmacokinetics: Area under the concentration-time curve (AUC)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RARP + IS-002 + intraoperative near-infrared imagingExperimental Treatment3 Interventions

Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.

Group II: RARP + IS-002Placebo Group2 Interventions

Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to prevent cancer growth, and chemotherapy, which targets rapidly dividing cells. Radiopharmaceuticals like Lutetium-177-PSMA target prostate-specific membrane antigens to deliver radiation directly to cancer cells. The IS-002 trial involves a fluorescent agent used during surgery to visualize cancerous tissues, enhancing precision in tumor removal. These mechanisms are crucial as they offer targeted approaches to manage and treat prostate cancer, potentially improving outcomes and reducing side effects for patients.

225 Ac-PSMA-617-targeted alpha therapy for the treatment of metastatic castration-resistant prostate cancer: A systematic review and meta-analysis.Lutetium-177-labelled anti-prostate-specific membrane antigen antibody and ligands for the treatment of metastatic castrate-resistant prostate cancer: a systematic review and meta-analysis.[177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study.