MK36 late phase II. Open-label study to assess efficacy and safety of a single dose (i.v.) of NMK36 in patients with prostate cancer
Phase 2
Completed
- Conditions
- Prostate cancer
- Registration Number
- JPRN-jRCT2080221765
- Lead Sponsor
- ihon Medi-Physics Co., Ltd.
- Brief Summary
In terms of efficacy, the diagnostic power for regional lymph node metastasis did not differ significantly between NMK36-PET/CT and contrast CT. In terms of safety, this method is tolerable in clinical use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
Patients with biopsy-proven prostate cancer.
-Patients who are to have radical prostatectomy or hormone treatment.
Exclusion Criteria
-Patients with treated prostate cancer.
-Patients with active double cancer.
-Patients with bone-marrow, hepatic or renal dysfunction.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety: subjective/objective symptoms, electrocardiogram exams, vital signs, laboratory tests<br>Efficacy: diagnostic accuracy of regional lymph node metastases<br>-
- Secondary Outcome Measures
Name Time Method efficacy<br>Efficacy: diagnostic performance of regional lymph node metastases, diagnostic performance of bone metastases, imaging performance of primary tumor, range of administered radioactivity, range of PET imaging time<br>-