DD-723 Phase III Clinical Trial (Prostate)
Phase 3
- Conditions
- Subjects with suspected prostate cancer
- Registration Number
- JPRN-jRCT2080221271
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 120
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection rate of prostate cancer in the subjects<br>Biopsy results obtained at each participating institution
- Secondary Outcome Measures
Name Time Method 1. Detection rate of prostate cancer per biopsy core<br>2. Assessment of the degree of malignancy<br>3. Assessment of contrast effect<br><br>1, 2. Biopsy results obtained at each participating institution<br>3. Assessment by investigator