Subjects with suspected prostate cancer
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Subjects with suspected prostate cancer who are undergoing prostate biopsy. - Subjects whose most recent PSA level is between 20.0 ng/mL and 4.0 ng/mL. - Subjects aged >=20 years old at the time of informed consent.
Exclusion criteria
Exclusion criteria: - Items listed in the package insert (including absolute contraindications, careful administration, and precautions) to ensure safety. - Items related to safety and ethics. - Items related to surgery, procedures, and treatment that are considered likely to influence assessment of the efficacy and safety of DD-723.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of prostate cancer in the subjects Biopsy results obtained at each participating institution | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Detection rate of prostate cancer per biopsy core 2. Assessment of the degree of malignancy 3. Assessment of contrast effect 1, 2. Biopsy results obtained at each participating institution 3. Assessment by investigator | — |