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NCT Number: NCT01667536

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug: 99mTc-MIP-1404

Drug

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

Other names: MIP-1404

Primary outcomes

  1. Assess the 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

    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 outcomes

  1. Assess the Ability of 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

    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.

  2. Assess the Ability of 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

    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.

  3. Assess the Ability of 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

    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.

  4. Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.

    Time frame: 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.

  5. Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Molecular Insight Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 17, 2012
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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