Trial Outcomes & Findings for A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology (NCT NCT01667536)

NCT ID: NCT01667536

Last Updated: 2017-02-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

Within 3-6 hours of dosing SPECT/CT images will be taken

Results posted on

2017-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	105
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug: 99mTc-MIP-1404 n=105 Participants 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
Age, Continuous	63.2 years STANDARD_DEVIATION 6.8 • n=93 Participants
Gender Female	0 Participants n=93 Participants
Gender Male	105 Participants n=93 Participants

PRIMARY outcome

Timeframe: Within 3-6 hours of dosing SPECT/CT images will be taken

Population: The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)

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.

Outcome measures

Outcome measures
Measure	Drug: 99mTc-MIP-1404 n=104 Participants 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	Drug: 99mTc-MIP-1404 + MRI Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.	94.2 % sensitivity Interval 89.2 to 97.0	—

SECONDARY outcome

Timeframe: Within 3-6 hours of dosing SPECT/CT images will be taken

Population: The primary analysis population, defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results, was used for this endpoint. A total of 3025 nodes were removed from 103 subjects (mean 29.6, range 1-88). Of these, 79 nodes were positive by pathology in 33 subjects.

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.

Outcome measures

Outcome measures
Measure	Drug: 99mTc-MIP-1404 n=33 Participants 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	Drug: 99mTc-MIP-1404 + MRI Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes	33.3 % sensitivity Interval 19.8 to 46.9	—

SECONDARY outcome

Timeframe: Within 3-6 hours of dosing SPECT/CT images will be taken

Population: The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)

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.

Outcome measures

Outcome measures
Measure	Drug: 99mTc-MIP-1404 n=519 Prostate Segments 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	Drug: 99mTc-MIP-1404 + MRI Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland	44.4 % sensitivity Interval 36.1 to 45.0	—

SECONDARY outcome

Timeframe: Within 3-6 hours of dosing SPECT/CT images will be taken

Population: The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)

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.

Outcome measures

Outcome measures
Measure	Drug: 99mTc-MIP-1404 n=1144 Lymph Node Segments 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	Drug: 99mTc-MIP-1404 + MRI Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions	8.1 % sensitivity Interval 3.2 to 19.3	—

SECONDARY outcome

Timeframe: Within 3-6 hours of dosing SPECT/CT images will be taken

Population: All subjects who completed prostate SPECT/CT MIP-1404 and MRI imaging and had histopathology results.

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.

Outcome measures

Outcome measures
Measure	Drug: 99mTc-MIP-1404 n=96 Participants 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	Drug: 99mTc-MIP-1404 + MRI n=96 Participants Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.	93.8 % specificity	85.4 % specificity

SECONDARY outcome

Timeframe: Within 3-6 hours of dosing SPECT/CT images will be taken

Population: All subjects who completed lymph node SPECT/CT MIP-1404 and MRI imaging, underwent EPLND, and had histopathology results.

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.

Outcome measures

Outcome measures
Measure	Drug: 99mTc-MIP-1404 n=33 Participants 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	Drug: 99mTc-MIP-1404 + MRI n=32 Participants Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.	33.3 % sensitivity	12.5 % sensitivity

Adverse Events

Drug: 99mTc-MIP-1404

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Director, Clinical Science Communications

Progenics Pharmaceuticals, Inc.

Phone: 914 784-1825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60