Clinical trial · Interventional
This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer.
A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Safety of 68Ga-NYM032 Injection PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer
NCT07649122CI-TRIAL-00114839recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68-Ga-NYM032 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68-Ga-NYM032
- interventionNames
- Diagnostic Test: 68-Ga-NYM032
Primary outcomes (1)
- measure
- PPV
- timeFrame
- up to12 months
- description
- Positive predictive value (PPV)were calculated on a per-patient basis on 68Ga-NYM032 PET/CT for detection of tumor location confirmed by the composite truth standard.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.