A clinical study in men with prostate cancer undergoing surgery to assess the accuracy of 99mTc-MIP-1404 imaging as compared to pathology results

• Conditions: Prostate Cancer within prostate gland and metastatic prostate cancer in regional lymph nodes; MedDRA version: 14.1Level: LLTClassification code 10007113Term: Cancer of prostateSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001864-30-NL
• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-03
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Subjects must meet all of the following criteria to be enrolled in this study:
1. Male aged 21 years or older.
2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
3. Biopsy confirmed presence of adenocarcinoma of the prostate gland.
4. At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score of greater than or equal to 130
5. Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.
6. Agree to use an acceptable form of birth control for a period of 7 days after the 99mTc-MIP-1404 injection
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Subjects must not meet any of the following criteria to be enrolled in this study:
1. Participating would significantly delay the scheduled standard of care therapy.
2. Administered a radioisotope within 5 physical half lives prior to study drug injection.
3. 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.
4. Have a contraindication for MR imaging.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified