Phase IIb Trial to Investigate the Safety and Efficacy of OTL78 Injection (Zopocianine)
21. juli 2026 opdateret af: Clinton Bahler
Safety and Efficacy of OTL78 (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for Intraoperative Imaging of Prostate Cancer: A Phase IIb Trial
This study is being done to support the selection of single dose and timing regimen of Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging to improve the detection of malignant (growing in an uncontrolled way) tissue in adult patients undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Prostate cancer (PCa) is the second leading cause of cancer-related death behind lung cancer. Prostate cells express Prostate Specific Membrane Antigen (PSMA), which is overexpressed in PCa cells in over 90% of patients. On Target has developed a PSMA-targeted agent, the drug product OTL78, that fluoresces under NIR illumination to help with the identification of prostate cancer tissue during resection surgery that has extended beyond the capsule of the prostate into adjacent tissue and lymph nodes. Intra-operative identification of cancer tissue using real-time imaging modalities that could improve tumor identification, demarcation and lymph node involvement may provide a very useful tool to reduce the frequency of residual cancer and increase complete removal of locally involved lymph nodes.
This study is an open label trial of an imaging agent, PSMA targeted fluorescent dye (zopocianine, OTL78), in up to 32 participants with biopsy confirmed PCa who have been scheduled to undergo a laparoscopic radical prostatectomy with pelvic lymph node dissection in order to confirm the optimal dose and administration-to-surgery interval of the drug in visualizing cancerous tissue during a standard of care radical prostatectomy.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
36
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Brandon Garver
- Telefonnummer: 317-278-4766
- E-mail: brwgarve@iu.edu
Studiesteder
-
-
Indiana
-
Carmel, Indiana, Forenede Stater, 46032
- Indiana University Health North Hospital
-
Kontakt:
- Brandon Garver
- Telefonnummer: 317-278-4766
- E-mail: brwgarve@iu.edu
-
Ledende efterforsker:
- Clint Bahler, MD
-
Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University School of Medicine
-
Kontakt:
- Brandon Garver
- Telefonnummer: 317-278-4766
- E-mail: brwgarve@iu.edu
-
Ledende efterforsker:
- Clint Bahler, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Provision of signed and dated informed consent and HIPAA form
- Male participants 18 years of age and older
Known primary prostate cancer and any one of the following:
- Grade group 3-5;
- Suspected extra-prostatic extension (EPE) or seminal vesicle invasion (SVI);
- Suspected lymph node metastasis (clinical stage cN1) by magnetic resonance imaging or by Prostate Specific Membrane Antigen positron emission tomography
- Planned to undergo a standard of care robotic prostatectomy and lymph node dissection
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
- Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
- Patient scheduled to have or has had a PSMA-PET Scan for surgical treatment planning within 12 months of surgery.
Exclusion Criteria:
- The surgeon plans to perform an extraperitoneal approach
- History of anaphylactic reactions to products containing indocyanine green
History of allergy to any of the components of ZOPOCIANINE:
- 2-[3-(1,3-dicarboxypropyl)ureido] pentanedioic acid (DUPA)
- Polyethylene glycol-dipeptide linker
- Chlorodye
Impaired renal or hepatic function:
- Renal: creatinine clearance (eGFR) < 50 mL/min
- Hepatic: total bilirubin > 2 × upper limit of normal or ALT/AST > 3 × upper limit of normal.
- Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening calculated via the Bazett formula.
- Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 0.06mg/kg ZOPOCIANINE given 1-7 days prior to surgery
A single dose of 0.06mg/kg ZOPOCIANINE (given 1-7 days prior to surgery) used with NIR fluorescent imaging during prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
|
A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of subjects who have a Clinically Significant Event
Tidsramme: Day of surgery
|
a) Histologically confirmed cancer in residual non-nodal soft tissue resected solely because of "NIR only" detection as suspicious following prostatectomy.
b) One or more resected NIR- positive lymph nodes that contain metastatic disease as confirmed by pathology.
|
Day of surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Påvisning af primær kræft
Tidsramme: Operationens dag
|
For primær kræft er antallet af læsioner, der er enten: fluorescenspositive og prostatacancer positive (dvs. ægte positiv); fluorescens positiv men kræft negativ (dvs. falsk positiv); fluorescens negativ men kræftpositiv (dvs. falsk negativ); eller fluorescens negativ og kræft negativ (dvs. sandt negativt).
Vi vil overveje sygdomstilstand ved fire (4) definerede prostatregioner - højre bageste, venstre bageste, anterior og ved blærehalsen
|
Operationens dag
|
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Udførelse af plan for før kirurgi
Tidsramme: Operationens dag
|
Pre-operationsplanen vil blive dokumenteret og sammenlignet med den dokumenterede operation, der udføres, hvis kirurg rapporterer om ændringer i omfang fra den første plan.
|
Operationens dag
|
|
Sikkerhed og tolerabilitet af zopocianin
Tidsramme: Screening til 6 ugers opfølgning
|
Forekomst af alle årsagssammenhængende AE'er og alle SAE'er
|
Screening til 6 ugers opfølgning
|
|
Detection of Metastatic Cancer
Tidsramme: Day of surgery
|
For metastatic cancer spread to lymph nodes, the number of lesions that are either: fluorescence positive, and prostate cancer positive (i.e., true positive); fluorescence positive but cancer negative (i.e., false positive); fluorescence negative but cancer positive (i.e., false negative); or, fluorescence negative and cancer negative (i.e., true negative).
We will use six (6) defined lymph node regions (external iliac, internal iliac, common iliac and right and left)
|
Day of surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Clint Bahler, MD, Indiana University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. februar 2027
Studieafslutning (Anslået)
1. april 2027
Datoer for studieregistrering
Først indsendt
21. juli 2026
Først indsendt, der opfyldte QC-kriterier
21. juli 2026
Først opslået (Faktiske)
24. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UROL-CC-IUSCCC-0965
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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