Firefly Fluorescent Imaging + IS-002 for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Intuitive Surgical
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have received certain therapies like hormonal therapy or are currently on an investigational drug, you may not be eligible.
What data supports the effectiveness of the treatment Firefly Fluorescent Imaging + IS-002 for Prostate Cancer?
The research indicates that robotic-assisted laparoscopic prostatectomy (RARP) with pelvic lymph node dissection (PLND) is a well-established method for treating localized prostate cancer, and the use of robotic assistance in these procedures is associated with varying outcomes. However, specific data on the effectiveness of Firefly Fluorescent Imaging or IS-002 in this context is not directly provided in the available research.
12345Is robotic-assisted prostate surgery generally safe for humans?
Robotic-assisted prostate surgery, like robotic-assisted laparoscopic prostatectomy (RALP), is generally considered safe, but there can be complications such as symptomatic lymphoceles (fluid-filled sacs) in up to 10% of cases. Equipment malfunctions can also occur, which might require changing the surgical approach.
16789What makes the Firefly Fluorescent Imaging + IS-002 treatment unique for prostate cancer?
This treatment is unique because it uses fluorescent imaging to enhance the precision of robotic-assisted prostate surgery, allowing surgeons to better visualize and preserve important structures like nerves and lymph nodes, potentially improving surgical outcomes and reducing complications.
1011121314Eligibility Criteria
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.Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
MSKCCNew York, NY
Johns HopkinsBaltimore, MD
Mayo ClinicRochester, MN
UCSFSan Francisco, CA
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Who is running the clinical trial?
Intuitive SurgicalLead Sponsor
References
Clinical Importance of a Peritoneal Interposition Flap to Prevent Symptomatic Lymphoceles after Robot-Assisted Radical Prostatectomy and Pelvic Lymph Node Dissection: A Systematic Review and Meta-Analysis. [2022]Robot-assisted radical prostatectomy (RARP) including pelvic lymph node dissection (PLND) is the current state of the art in surgical therapy of localized prostate cancer with intermediate or high risk. PLND in particular is associated with morbidity inherent to this method; the rate of symptomatic lymphoceles (sLCs), for example, ranges up to 10%.
Pelvic lymph node dissection for patients with elevated risk of lymph node invasion during radical prostatectomy: comparison of open, laparoscopic and robot-assisted procedures. [2021]Published outcomes of pelvic lymph node dissection (PLND) during robot-assisted laparoscopic prostatectomy (RALP) demonstrate significant variability. The purpose of the study was to compare PLND outcomes in patients at risk for lymph node involvement (LNI) who were undergoing radical prostatectomy (RP) by different surgeons and surgical approaches.
Robotic-assisted pelvic lymph node dissection for prostate cancer: frequency of nodal metastases and oncological outcomes. [2018]Limited data are available regarding the oncologic efficacy of pelvic lymph node dissection (PLND) performed during robotic-assisted laparoscopic prostatectomy (RALP) for prostate cancer. We aimed to determine the frequency of pelvic lymph node metastasis and oncological outcomes following RALP with PLND in patients who did not receive adjuvant androgen deprivation therapy (ADT).
The clinical impact of robot-assisted laparoscopic rectal cancer surgery associated with robot-assisted radical prostatectomy. [2022]Robot-assisted laparoscopic surgery has been performed in various fields, especially in the pelvic cavity. However, little is known about the utility of robot-assisted laparoscopic rectal cancer surgery associated with robot-assisted radical prostatectomy (RARP). We herein report the clinical impact of robot-assisted laparoscopic rectal cancer surgery associated with RARP.
Comparison of lymph node yield in robot-assisted laparoscopic prostatectomy with that in open radical retropubic prostatectomy. [2011]• To investigate both the feasibility and the adequacy of pelvic lymph node dissection (PLND) during robot-assisted laparoscopic prostatectomy (RALP) by comparing lymph node yields obtained during RALP with those obtained during traditional open retropubic radical prostatectomy (RRP).
Robot-assisted laparoscopic prostatectomy: a 2010 update. [2011]To build on the previous article and further explore the safety and efficacy of robotic-assisted laparoscopic prostatectomy (RALP) in the first 100 cases from a single institution in New Zealand.
Current evidence between hospital volume and perioperative outcome: Prospective assessment of robotic radical prostatectomy safety profile in a regional center of medium annual caseload. [2021]We aimed to present the safety profile of robotic radical prostatectomy (RARP) performed in a single center of medium surgical volume since its introduction and identify predictors of postoperative complications.
Robotic equipment malfunction during robotic prostatectomy: a multi-institutional study. [2016]Robotic-assisted laparoscopic prostatectomy (RALP) is growing in popularity as a treatment option for prostate cancer. As a new technology, little is known regarding the reliability of the da Vinci robotic system. Intraoperative robotic equipment malfunction may force the surgeon to convert the procedure to an open or pure laparoscopic procedure, or possibly even abort the procedure. We report the first large-scale, multi-institutional review of robotic equipment malfunction.
Trends in risk-group distribution and Pentafecta outcomes in patients treated with nerve-sparing, robot-assisted radical prostatectomy: a 10-year low-intermediate volume single-center experience. [2021]To evaluate the trends in risk-group distribution and Pentafecta outcomes in patients treated with nerve-sparing (NS), robot-assisted radical prostatectomy (RARP) in a single low-intermediate volume prostate cancer (PCa) center over a 10-year period.
Intraoperative Fluorescent Image Guidance for Nerve-Sparing Prostatectomy: A Review of Historical Context and Current Research. [2023]Fluorescent probes in the near-infrared (NIR) range have immense potential to improve observation of positive margins, lymph nodes, and nerves in prostatectomy. Development of fluorescent dyes and mechanisms of cellular uptake paved the way for the current emerging technologies. However, intracellular transport of fluorophores proved to be logistically challenging with respect to intraoperative deployment. Peptide-based probes with high specificity for nerves enabled broader and more rapid labeling. Key features of the ideal probe include selectivity, minimal background noise, safety, and low cost. Human neuropeptide 401 (HNP401) and oxazine-based probes perform well in these categories. As for tumor-specific labeling, prostate specific membrane antigen is relatively selective for the prostate and can be conjugated to a fluorophore. NIR spectrum emission is an ideal range for clinical imaging use, as fluorescence occurs outside the field of visible light, and tissue optical properties diverge significantly at the visible-NIR transition. Indocyanine, carbocyanine, and fluorescein derivatives are common fluorophore conjugates for the probes. Finally, to harness the power of fluorescence intraoperatively, the surgeon must look through a specialized lens. Multiphoton microscopy, optical coherence tomography, and confocal laser endomicroscopy have emerged as frontrunners in this arena. As with any evolving technology, ongoing research is expanding the applications of fluorescent intraoperative imaging in prostate surgery. Innovations in camera technology, dye selection, and image processing are refining the technique's capabilities. A core challenge of these technologies translating into the operating room relates to size and the ability to view objects at vastly different magnifications. Dual modality zoom settings are promising solutions. Furthermore, interdisciplinary collaboration between surgeons, imaging specialists, and researchers continues to drive advancements. In conclusion, fluorescent intraoperative imaging has the potential to usher in a new era of precision and safety in prostate surgery.
[Clinical value of fluorescence laparoscopy in pelvic lymph node dissection for intermediate- and high-risk prostate cancer patients]. [2023]We explore the clinical value of fluorescence laparoscopy in the management of intermediate- and high-risk prostate cancer (PCa) patients by radical prostatectomy plus pelvic lymph node dissection (RP+PLND).
Robot-Assisted Prostate-Specific Membrane Antigen-Radioguided Surgery in Primary Diagnosed Prostate Cancer. [2023]The objective of this study was to evaluate the safety and feasibility of 99mTc-based prostate-specific membrane antigen (PSMA) robot-assisted-radioguided surgery to aid or improve the intraoperative detection of lymph node metastases during primary robot-assisted radical prostatectomy (RARP) for prostate cancer (PCa). Methods: Men with primary high-risk PCa (≥ cT3a, International Society of Urological Pathology (ISUP) grade group ≥ 3 or prostate-specific antigen of ≥ 15 ng/mL) with potential lymph node metastasis (Briganti nomogram risk > 10% or on preoperative imaging) were enrolled in the study. Patients underwent staging 68Ga-PSMA PET/CT scanning. Preoperatively, a 99mTc-labeled PSMA ligand (99mTc PSMA I&S; 500 MBq) was administered followed by SPECT/CT. A RARP including extended pelvic lymph node dissection was performed, with intraoperative tracing of PSMA-avid tissues using a prototype DROP-IN γ-probe. Resected specimens were also measured ex vivo. Histopathologic concordance with probe findings was evaluated. A radiotracer count of ≥ 1.5 times the background reference (in vivo), and ≥ 10 (absolute count) in the ex vivo setting, was considered positive. Results: Twelve patients were included (median age, 68 y, and prostate-specific antigen, 9.15 ng/mL). Most of the patients harbored ISUP 5 PCa (75%) and had avid lymph nodes on preoperative PSMA PET (64%). The DROP-IN probe aided resection of PSMA-avid (out-of-template) lymph nodes and residual disease at the prostate bed. Eleven metastatic lymph nodes were identified by the probe that were not observed on preoperative 68Ga-PSMA PET/CT. Of the 74 extraprostatic tissue specimens that were resected, 22 (29.7%) contained PCa. The sensitivity, specificity, positive predictive value, and negative predictive value of inpatient use of the γ-probe were 76% (95% CI, 53%-92%), 69% (95% CI, 55%-81%), 50%, and 88%, respectively. Ex vivo, the diagnostic accuracy was superior: 76% (95% CI, 53%-92%), 96% (95% CI, 87%-99%), 89%, and 91%, respectively, for sensitivity, specificity, positive predictive value, and negative predictive value. Of the missed lymph nodes in vivo (n = 5) and ex vivo (n = 5), 90% were micrometastasis (≤3 mm). No complications greater than Clavien-Dindo Grade I occurred. Conclusion: Robot-assisted 99mTc-based PSMA-radioguided surgery is feasible and safe in the primary setting, optimizing the detection of nodal metastases at the time of RARP and extended pelvic lymph node dissection. Further improvement of the detector technology may optimize the capabilities of robot-assisted 99mTc-based PSMA-radioguided surgery.
Impact of indocyanine green-guided extended pelvic lymph node dissection during robot-assisted radical prostatectomy. [2021]To evaluate the effectiveness of indocyanine green-guided extended pelvic lymph node dissection during robot-assisted radical prostatectomy for intermediate- to high-risk prostate cancer.
First-in-patient study of OTL78 for intraoperative fluorescence imaging of prostate-specific membrane antigen-positive prostate cancer: a single-arm, phase 2a, feasibility trial. [2023]Targeted real-time imaging during robot-assisted radical prostatectomy provides information on the localisation and extent of prostate cancer. We assessed the safety and feasibility of the prostate-specific membrane antigen (PSMA)-targeted fluorescent tracer OTL78 in patients with prostate cancer.