Prostate cancer
Conditions
Interventions
OTL78
Sponsors
OnTarget Laboratories
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers (part A) 1) Male and 18-65 years old at screening. 2) Able and willing to comply with study procedures, with signed and dated informed consent obtained before any study-related procedures are performed. 3) Agree to use an effective method of contraception for 90 days after administration. 4) A body mass index is *30 kg/m2. 5) The subject is healthy with no acute or chronic medical illnesses, has a normal physical examination, and normal vital signs findings at screening. 6) The subject*s screening 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the investigator. 7) Negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus. 8) Negative test results for drug and alcohol screening. 9) Absence of any psychological, familial, sociological or geographical condition that at the discretion of the investigator could potentially hamper compliance with the study protocol and follow-up schedule; such conditions should be discussed with the patient during the prescreening period. Patients (part B) 1) Male patients > 18 years of age and older at screening. 2) Able and willing to comply with study procedures, and signed and dated informed consent obtained before any study-related procedures are performed. 3) Known or high clinical suspicion of (primary or recurrent) prostate cancer scheduled to undergo a pelvic lymph node dissection for salvage or staging at the LUMC. 4) The 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the investigator 5) Chronic or acute medical illness that in the discretion of the investigator may confound or complicate the findings in this study 6) Patients are clinically fit for surgery 7) Agree to use an effective method of contraception for 90 days after administration 8) Absence of psychological familial, sociological or geographical condition that at the discretion of the investigator could potentially hamper compliance with the study protocol and follow- up schedule; such conditions should be discussed with the patient during the prescreening period. Patients (part C) 1) Male patients > 18 years of age and older at screening. 2) Able and willing to comply with study procedures, and signed and dated informed consent obtained before any study-related procedures are performed. 3) Known or high clinical suspicion of prostate cancer (Gleason score 7+) planned for a prostatectomy at the NKI. 4) The 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the investigator 5) Chronic or acute medical illness that in the discretion of the investigator may confound or complicate the findings in this study Protocol Version 1.5 / 17-Jan-2020 Page 22 of 68 6) Patients are clinically fit for surgery 7) Agree to use an effective method of contraception for 90 days after administration 8) Absence of psychological familial, sociological or geographical condition that at the discretion o
Exclusion criteria
Exclusion criteria: Healthy volunteers (part A) 1) Female subjects 2) Known acute or chronic disease, abnormal physical examination or blood tests of clinical significance. 3) The subject has previously been included in an OTL study. 4) Use of prescription drugs within 30 days of screening and during study participation 5) Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year. 6) History of clinically significant allergies or anaphylactic reactions. 7) History of allergy to any of the components of OTL78 or excipients (see Investigator*s Brochure). Patients (part B) 1) Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient 2) History of clinically significant allergies or anaphylactic reactions 3) History of allergy to any of the components of OTL78 or excipients (see Investigator*s Brochure) 4) Impaired renal function defined as eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: healthy volunteers (n= up to 15) Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dose of OTL78 Part B/part C: patients (n=24) Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dose of OTL78 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: healthy volunteers (n= up to 15) Secondary objective: - To assess the pharmacodynamics of OTL78 by measuring the temporal relationship of fluorescence of superficial tissues (skin/veins and mucosa). Part B/Part C: patients (n=24) Secondary objectives: - To estimate the Sensitivity (or True Positive rate, TP/(TP+FN)) of OTL78 for detection of tissues expressing PSMA or prostate cancer during near infrared imaging (NIR) - To estimate the Specificity (or True Negative rate, TN/(TN+FP)) of OTL78 for detection of PSMA+ tissue and prostate cancer cells during near infrared imaging (NIR) - To estimate the False Positive rate (FP/(FP+TN)) of OTL78 for detection of tissues expressing PSMA or prostate cancer during near infrared imaging (NIR) - To estimate the False Negative rate (FN/(FN+TP)) of OTL78 for detection of PSMA+ tissues prostate cancer cells during near infrared imaging (NIR) - To evaluate the tumor to background ratio (TBR) Exploratory Objective: - To evaluate the surgeons* rating for the utility of OTL78 IV injection and imaging system in visualizing prostate cancer and/or lymph nodes during surgery | — |
Countries
Netherlands
Outcome results
None listed