NCT07615101 Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
| NCT ID | NCT07615101 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Norroy Bioscience Co., LTD |
| Condition | Prostate Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 365 participants |
| Start Date | 2026-08-06 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 365 participants in total. It began in 2026-08-06 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Patient is male and aged \>18 years old. 2. Biopsy proven prostate adenocarcinoma. 3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND). 4. ECOG performance status 0-2; expected survival ≥ 6 months. 6\. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT07615101 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07615101 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 365 participants.
Is NCT07615101 currently recruiting?
Yes, NCT07615101 is actively recruiting participants. Visit ClinicalTrials.gov or contact Norroy Bioscience Co., LTD to inquire about joining.
Where is the NCT07615101 trial being conducted?
This trial is being conducted at Nanjing, China, Wuxi, China.
Who is sponsoring the NCT07615101 clinical trial?
NCT07615101 is sponsored by Norroy Bioscience Co., LTD. The trial plans to enroll 365 participants.
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