Prostate Cancer within prostate gland and metastatic prostate cancer in regional lymph nodes MedDRA version: 14.1 Level: LLT Classification code 10007113 Term: Cancer of prostate System Organ Class: 100000004864
Conditions
Interventions
Product Name: 99mTc-MIP-1404
Pharmaceutical Form: Kit for radiopharmaceutical preparation
INN or Proposed INN: -
CAS Number: 1333117-95-5
Current Sponsor code: MIP-1404-201
Other descriptive name: MI
Sponsors
Molecular Insight Pharmaceuticals, Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this study: 1. Male aged 21 years or older. 2. Ability to provide signed informed consent and willingness to comply with protocol requirements. 3. Biopsy confirmed presence of adenocarcinoma of the prostate gland. 4. At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130 5. Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection. 6. Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc-MIP-1404 injection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: Subjects must not meet any of the following criteria to be enrolled in this study: 1. Participating would significantly delay the scheduled standard of care therapy. 2. Administered a radioisotope within 5 physical half lives prior to study drug injection. 3. Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study. 4. Have a contraindication for MR imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: . Assess the ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland . Assess the clinical safety of 99mTc-MIP-1404 ;Secondary Objective: . Assess the ability of 99mTc-MIP-1404 to detect the extent and location of prostate cancer within the prostate gland. .Assess the ability of 99mTc-MIP-1404 to detect metastatic prostate cancer within pelvic lymph nodes. . Assess the ability of 99mTc-MIP-1404 to detect the specific location of metastatic prostate cancer within anatomic pelvic lymph node regions . Assess the comparative performance of 99mTc-MIP-1404 against MRI for detection of prostate cancer within the prostate gland. . Assess the comparative performance of 99mTc-MIP-1404 against MRI for detection of metastatic prostate cancer within pelvic lymph nodes.;Primary end point(s): . Assess the ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland . Assess the clinical safety of 99mTc-MIP-1404 ;Timepoint(s) of evaluation of this end point: Post (after) histopathology processing of prostate and lymph node surgical samples | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The relative diagnostic accuracy of disease detection in the prostate gland and in the local lymph nodes using 99mTc-MIP-1404 imaging versus MRI in this study population will be assessed as a secondary endpoint.;Timepoint(s) of evaluation of this end point: Post (after) histopathology processing of prostate and lymph node surgical samples | — |
Countries
Belgium, Czech Republic, Hungary, Netherlands, Russian Federation, United States
Contacts
Public ContactJohn W Babich
Molecular Insight Pharmaceuticals, Inc
Outcome results
None listed