NMK36 late phase II. Open-label study to assess efficacy and safety of a single dose (i.v.) of NMK36 in patients with prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221765

Enrollment

Registered

2012-04-16

Start date

2012-06-27

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 are to have radical prostatectomy or hormone treatment.

Exclusion criteria

Exclusion criteria: -Patients with treated prostate cancer. -Patients with active double cancer. -Patients with bone-marrow, hepatic or renal dysfunction.

Design outcomes

Primary

Measure	Time frame
safety efficacy Safety: subjective/objective symptoms, electrocardiogram exams, vital signs, laboratory tests Efficacy: diagnostic accuracy of regional lymph node metastases -	—

Secondary

Measure	Time frame
efficacy 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 -	—

Countries

Japan

Outcome results

None listed

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