Health TrialsbyHealthPanel

Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection

ConditionsProstate Cancer SurgeryProstate Cancer Metastatic Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorClinton Bahler

About this trial

This study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent and HIPAA form

Male subjects 18 years of age and older

Suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)),

3 or more biopsy cores of grade group 3-5;

Disqualifiers

The surgeon plans to perform an extraperitoneal approach

History of anaphylactic reactions to products containing indocyanine green

2-[3-(1,3-dicarboxypropyl)ureido] pentanedioic acid (DUPA)

Polyethylene glycol-dipeptide linker

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.03mg/kg ZOPOCIANINE given day of surgery

    Drug

    A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

  • 0.06mg/kg ZOPOCIANINE given day of surgery

    Drug

    A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

  • 0.03mg/kg ZOPOCIANINE given day prior to surgery

    Drug

    A single dose of 0.03mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

  • 0.06mg/kg ZOPOCIANINE given days prior to surgery

    Drug

    A single dose of 0.06mg/kg ZOPOCIANINE used with NIR fluorescent imaging during prostatectomy and lymph node dissection

Treatment groups

22 Participants
are divided into 4 treatment groups
Group A: 0.03mg/kg ZOPOCIANINE given day of surgeryExperimental treatment 1 intervention
Group B: 0.06mg/kg ZOPOCIANINE given day prior to surgeryExperimental treatment 1 intervention
Group C: 0.03mg/kg ZOPOCIANINE given day prior to surgeryExperimental treatment 1 intervention
Group D: 0.06mg/kg ZOPOCIANINE given 2-7 days prior to surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Porportion of subjects who have a Clinically Significant Event

1. Histologically confirmed cancer in residual non-nodal soft tissue resected solely because of "NIR only" detection as suspicious following prostatectomy. 2. One or more resected NIR- positive lymph nodes that contain metastatic disease as confirmed by pathology.

Time frame
Day of surgery

Secondary outcomes

1

Detection of Primary cancer

For primary cancer, 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 consider disease state at four (4) defined prostate regions - right posterior, left posterior, anterior, and at the bladder neck

Time frame
Day of surgery
2

Detection of Metastatic Cancer

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).

Time frame
Day of surgery
3

Execution of pre-surgery plan

The pre-surgery plan will be documented and compared to the documented surgery performed if surgeon reports of changes in scope from initial plan.

Time frame
Day of surgery
4

Safety and tolerability of ZOPOCIANINE

Incidence rates of all causally related AEs and all SAEs

Time frame
Screening to 6 week follow-up

Other outcomes

1

Cancer detected by NIR only

Number of tissues that are fluorescence positive and histologically confirmed cancer which were not detected by pre-operative PSMA-PET scanning.

Time frame
Day of Surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinton Bahler

Lead sponsor

Indiana University

Sponsor institution

Indiana University

Collaborator

On Target Laboratories, LLC

Collaborator

Source ClinicalTrials.gov
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