Phase 2
N=105
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01667536 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland. — 94.2 % sensitivity
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Drug: 99mTc-MIP-1404 (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland. |
94.2 | — |
| SECONDARY Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes |
33.3 | — |
| SECONDARY Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland |
44.4 | — |
| SECONDARY Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions |
8.1 | — |
| SECONDARY Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland. |
93.8; 85.4 | — |
| SECONDARY Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes. |
33.3; 12.5 | — |
Summary
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01667536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.