Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
Open-label, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
1 other identifier
interventional
365
1 country
2
Brief Summary
The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2026
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2026
CompletedFirst Posted
Study publicly available on registry
May 29, 2026
CompletedStudy Start
First participant enrolled
August 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
August 17, 2026
August 1, 2026
11 months
May 22, 2026
August 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
sensitivity and specificity
Assessing the sensitivity and specificity of 68Ga-NYM032 Injection positron emission tomography (PET) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
up to 30 days
Study Arms (1)
68-Ga-NYM032
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient is male and aged \>18 years old.
- Biopsy proven prostate adenocarcinoma.
- Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
- ECOG performance status 0-2; expected survival ≥ 6 months.
- \. Ability to understand a written informed consent document, and the willingness to sign it.
You may not qualify if:
- \. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.
- \. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
- \. Known hypersensitivity to the active ingredient or excipients of the study drug.
- \. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
- \. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2026
First Posted
May 29, 2026
Study Start
August 6, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
August 17, 2026
Record last verified: 2026-08