A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01667536

Enrollment

105

Registered

2012-08-17

Start date

2012-08-31

Completion date

2013-12-31

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

PROSTATE CANCER, HIGH-RISK, PROSTATECTOMY SURGERY, NEWLY DIAGNOSED

Brief 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.

Detailed description

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.

Interventions

DRUGDrug: 99mTc-MIP-1404

A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.	Within 3-6 hours of dosing SPECT/CT images will be taken	For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.

Secondary

Measure	Time frame	Description
Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes	Within 3-6 hours of dosing SPECT/CT images will be taken	For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.
Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland	Within 3-6 hours of dosing SPECT/CT images will be taken	For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined tissue-segments) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.
Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions	Within 3-6 hours of dosing SPECT/CT images will be taken	For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined tissue-segments) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.
Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.	Within 3-6 hours of dosing SPECT/CT images will be taken	Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.
Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.	Within 3-6 hours of dosing SPECT/CT images will be taken	Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.

Countries

Belgium, Czechia, Hungary, Italy, Netherlands, Poland, Russia, United States

Participant flow

Participants by arm

Arm	Count
Drug: 99mTc-MIP-1404 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	105
Total	105

Baseline characteristics

Characteristic	Drug: 99mTc-MIP-1404
Age, Continuous	63.2 years STANDARD_DEVIATION 6.8
Gender Female	0 Participants
Gender Male	105 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 105
serious Total, serious adverse events	0 / 105

Outcome results

Primary

Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.

For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.