Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment drug: 99mtc-mip-1404
Phase phase 2
Sponsor Molecular Insight Pharmaceuticals, Inc.
Start date August 2012
End date December 2013
Trial size 100 participants
Trial identifier NCT01667536, MIP-1404-201

Summary

This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
drug: 99mtc-mip-1404
A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Primary Outcomes

Measure
Ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland.
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
Clinical safety of 99mTc-MIP-1404
time frame: Vital signs will be taken at Pre-Dose and Post-Dose as well as between 3-6 hours post-dose. Lab samples: will be taken at Screening and Pre-Surgery (within 21 days of dosing)

Secondary Outcomes

Measure
Ability of 99mTc-MIP-1404 to detect the extent and location of prostate cancer within the prostate gland.
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
Ability of 99mTc-MIP-1404 to detect metastatic prostate cancer within pelvic lymph nodes.
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
Ability of 99mTc-MIP-1404 to detect the specific location of metastatic prostate cancer within anatomic pelvic lymph node regions.
time frame: Within 3-6 hours of dosing SPECT/CT images will be taken
Compare performance of 99mTc-MIP-1404 against MRI for detection of prostate cancer within the prostate gland.
time frame: The MRI will take place at Screening. SPECT/CT imaging will take place within 3-6 hours of dosing
Compare performance of 99mTc-MIP-1404 against MRI for detection of metastatic prostate cancer within pelvic lymph nodes.
time frame: The MRI will take place at Screening. SPECT/CT imaging will take place within 3-6 hours of dosing

Eligibility Criteria

Male participants at least 21 years old.

Inclusion Criteria: - Male aged 21 years or older. - Ability to provide signed informed consent and willingness to comply with protocol requirements. - Biopsy confirmed presence of adenocarcinoma of the prostate gland. - At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130. - Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection. - Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc MIP-1404 injection. Exclusion Criteria: - Participating would significantly delay the scheduled standard of care therapy. - Administered a radioisotope within 5 physical half lives prior to study drug injection. - 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. - Have a contraindication for MR imaging.

Additional Information

Official title A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology
Principal investigator Douglas Scherr, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Molecular Insight Pharmaceuticals, Inc..