Open-label study to assess safety and efficacy of a single dose (i.v.) of NMK36 in subjects with prostate cancer
Phase 2
Completed
- Conditions
- Prostate cancer
- Registration Number
- JPRN-jRCT2080221289
- Lead Sponsor
- ihon Medi-Physics Co., Ltd.
- Brief Summary
An initial evaluation of the safety and efficacy of a single intravenous dose of NMK36 in patients with prostate cancer indicated that the agent was clinically acceptable as regards safety and, in terms of efficacy, good delineation capability was confirmed for both primary tumours and metastases. The time-radioactivity curves for primary tumours, metastases and surrounding tissues provided detailed information about PET imaging conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 11
Inclusion Criteria
The subject has biopsy-proven prostate cancer.
-The subject has lymph node and/or bone metastasis from prostate cancer detected by CT, MRI or bone scintigraphy.
Exclusion Criteria
-The subject received treatment for prostate cancer.
-The subject has a dysfunction of bone-marrow, hepatic or renal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety: subjective/objective symptoms, electrocardiogram exam, vital signs,clinical test<br><br><br>efficacy<br>Efficacy: imaging charactaristics of primary and metastatic prostate cancer, range of administratored radioactivity, starting time for PET imaging
- Secondary Outcome Measures
Name Time Method other<br>None