Clinical trial · Interventional
The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
NCT04179968CI-TRIAL-00064817completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).
Conditions
Conditions (2)
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 |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga PSMA-11 injection | Drug | — | UNRESOLVED |
| Positron Emission Tomography/Computed Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with suspected prostate cancer
- description
- Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
- interventionNames
- Drug: 68Ga PSMA-11 injection
- Procedure: Positron Emission Tomography/Computed Tomography
Primary outcomes (2)
- measure
- Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging
- timeFrame
- During PET/CT imaging, up to 2 hours
- description
- Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
- measure
- Number of Primary Prostate Lesions Detected by mpMRI
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician * Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4 * In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level. * Patients must be scheduled for biopsy or radical prostatectomy * Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study * Patients must be medically stable as judged by the patient's physician * Patients must be able to lie still for a total of 60 minutes for the PET/CT scans * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study * Patients who have had a prior biopsy for prostate cancer cannot participate in the study * Patients who have been treated for cancers other than skin cancers * Subjects may not be receiving any other investigational agents for the treatment of the cancer under study * Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (\>200 kilograms or 440 pounds) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI * Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies
References
Publications (1)
- DERIVEDParrott D, Yuan Q, Pinho D, Xi Y, Costa DN, De Leon AD, Dakanali M, Sun X, Oz OK, Bowen S, Rofsky NM, Mathews D, Pedrosa I. Characterization of suspicious prostate lesions at multiparametric MRI with dynamic 68 Ga-Gozetotide PET/CT. EJNMMI Rep. 2025 Oct 13;9(1):35. doi: 10.1186/s41824-025-00268-2. PMID 41077599