Prostate Cancer (Diagnosis)Phase 3NCT07615101
Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
A Phase 3 study testing 68-Ga-NYM032 in people with Prostate Cancer (Diagnosis), run by Norroy Bioscience Co., LTD at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis)
- What is being tested?
- 68-Ga-NYM032
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 2 sitesChina
- Study dates
- 6 Aug 2026to 30 Jul 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 6. Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- 1. 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.
- 2. 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.
- 3. Known hypersensitivity to the active ingredient or excipients of the study drug.
- 4. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
- 5. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu
Hongqian Guo, MD, 13605171690, gymwpi@126.com
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu
Chunjing Yu, MD, 15312238622, ycj_wxd1978@163.com
About this study
Official title: 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.
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.
Read the detailed description
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Prostate-specific membrane antigen (PSMA) is a transmembrane surface protein highly overexpressed in over 90% of prostate cancer lesions.⁶⁸Ga-NYM032 Injection, a PSMA-targeted radiotracer, is indicated for PET/CT imaging in patients with prostate cancer. Patients will receive 68Ga-NYM032 imaging to identify pelvic lymph node involvement.
- Conditions
- Prostate Cancer (Diagnosis)
- Being tested
- 68-Ga-NYM032
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68-Ga-NYM032Drug
IV injection
| Study group | Role | What they receive |
|---|---|---|
| 68-Ga-NYM032 | Experimental | Not described Receives: Drug: 68-Ga-NYM032 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start6 Aug 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norroy Bioscience Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615101
- Sponsor's protocol ID
- G03202
- Status last verified
- Aug 2026
- First submitted
- 22 May 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No