An open-label study to explore the efficacy of NMK36 single-dose (i.v.) injection for diagnosis of regional lymph node metastasis in subjects with prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222656

Enrollment

Registered

2014-11-14

Start date

2014-12-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

investigational material(s) Generic name etc : fluciclovine(18F) INN of investigational material : fluciclovine(18F) Therapeutic category code : 43- Radioactive medicines Dosage and Administration for

185 MBq/2 mL when calibrated). control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Patients with biopsy-proven prostate cancer. -Patients who is scheduled for regional lymph node dissection.

Exclusion criteria

Exclusion criteria: -Patients with treated prostate cancer. -Patients with another type of cancer. -Patients with bone-marrow, hepatic or renal dysfunction.

Design outcomes

Primary

Measure	Time frame
efficacy Efficacy: diagnostic sensitivity of NMK36-PET/CT in diagnosing the metastatic regional lymph node	—

Secondary

Measure	Time frame
safety efficacy Efficacy: -diagnostic specificity and accuracy of NMK36-PET/CT for metastatic regional lymph node -diagnostic sensitivity of NMK36-PET/CT for metastatic regional lymph node (subgroup analysis for size of cancer) -comparison of the diagnosis with NMK36-PET/CT images to the pathological findings in diagnosing the metastatic regional lymph node which was not identified by contrast-enhanced CT -range of radioactivity dose Safety: subjective/objective symptoms, electrocardiogram exams, vital signs, laboratory tests	—

Measure

Time frame

safety efficacy Efficacy: -diagnostic specificity and accuracy of NMK36-PET/CT for metastatic regional lymph node -diagnostic sensitivity of NMK36-PET/CT for metastatic regional lymph node (subgroup analysis for size of cancer) -comparison of the diagnosis with NMK36-PET/CT images to the pathological findings in diagnosing the metastatic regional lymph node which was not identified by contrast-enhanced CT -range of radioactivity dose Safety: subjective/objective symptoms, electrocardiogram exams, vital signs, laboratory tests

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026