NCT07649122 This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer.
| NCT ID | NCT07649122 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Norroy Bioscience Co., LTD |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2026-08-31 |
| Primary Completion | 2028-06-30 |
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 232 participants in total. It began in 2026-08-31 with a primary completion date of 2028-06-30.
⚠ 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
This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.
Eligibility Criteria
Inclusion Criteria: 1. Patient is male and aged \>18 years old. 2. Participants with histopathologically confirmed prostate adenocarcinoma, who present with elevated PSA and suspected recurrence following radical prostatectomy and/or radiotherapy and/or other radical prostate cancer treatments (e.g., proton therapy, cryoablation, high-intensity focused ultrasound, etc.). (PSA must be measured within 30 days prior to screening.). (Meeting any one of the following criteria): 1. Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery; 2. Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir; 3. Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir. 3. ECOG performance status 0-2; expected survival ≥ 6 months. 4. 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 NCT07649122 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. 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 NCT07649122 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 232 participants.
Is NCT07649122 currently recruiting?
Yes, NCT07649122 is actively recruiting participants. Visit ClinicalTrials.gov or contact Norroy Bioscience Co., LTD to inquire about joining.
Where is the NCT07649122 trial being conducted?
This trial is being conducted at Nanjing, China, Wuxi, China.
Who is sponsoring the NCT07649122 clinical trial?
NCT07649122 is sponsored by Norroy Bioscience Co., LTD. The trial plans to enroll 232 participants.
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