Clinical trial · Interventional
68Ga PSMA in Preprostatectomy Patients
68Ga PSMA-HBED-CC in Intermediate to High-Risk Preprostatectomy Patients
NCT03388346CI-TRIAL-00074052completedPhase 2 / Phase 3Results 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)
This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.
Conditions
Conditions (4)
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 |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
| Prostatic Neoplasm of Uncertain Behavior | — | UNRESOLVED | — |
| Prostatic Neoplasms, Castration-Resistant | Prostate Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68 PSMA-HBED-CC PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga PSMA PET scan
- description
- Ga-68 PSMA-HBED-CC PET
- interventionNames
- Drug: Ga-68 PSMA-HBED-CC PET
Primary outcomes (4)
- measure
- Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis
- timeFrame
- within 2 weeks of prostatectomy
- description
- Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.
- measure
- Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven prostate adenocarcinoma * Intermediate to high-risk disease, defined as one of the following factors: PSA \> 10, T2b or greater, or a Gleason score of 7 or greater * A PSA level resulted within the past 2 months * Planned prostatectomy with lymph node dissection * Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months * Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu) * Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations * Ability to understand and the willingness to provide informed consent. Exclusion Criteria: * Cannot receive furosemide * Allergy to sulfa or sulfa-containing medications * History of Stevens-Johnson syndrome * Known Paget's disease * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
References
Publications (5)
- BACKGROUNDMaurer T, Gschwend JE, Rauscher I, Souvatzoglou M, Haller B, Weirich G, Wester HJ, Heck M, Kubler H, Beer AJ, Schwaiger M, Eiber M. Diagnostic Efficacy of (68)Gallium-PSMA Positron Emission Tomography Compared to Conventional Imaging for Lymph Node Staging of 130 Consecutive Patients with Intermediate to High Risk Prostate Cancer. J Urol. 2016 May;195(5):1436-1443. doi: 10.1016/j.juro.2015.12.025. Epub 2015 Dec 9. PMID 26682756
- BACKGROUNDvan Leeuwen PJ, Emmett L, Ho B, Delprado W, Ting F, Nguyen Q, Stricker PD. Prospective evaluation of 68Gallium-prostate-specific membrane antigen positron emission tomography/computed tomography for preoperative lymph node staging in prostate cancer. BJU Int. 2017 Feb;119(2):209-215. doi: 10.1111/bju.13540. Epub 2016 Jun 18. PMID 27207581
- BACKGROUNDEiber M, Maurer T, Souvatzoglou M, Beer AJ, Ruffani A, Haller B, Graner FP, Kubler H, Haberkorn U, Eisenhut M, Wester HJ, Gschwend JE, Schwaiger M. Evaluation of Hybrid (6)(8)Ga-PSMA Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. J Nucl Med. 2015 May;56(5):668-74. doi: 10.2967/jnumed.115.154153. Epub 2015 Mar 19. PMID 25791990
- BACKGROUNDAfshar-Oromieh A, Avtzi E, Giesel FL, Holland-Letz T, Linhart HG, Eder M, Eisenhut M, Boxler S, Hadaschik BA, Kratochwil C, Weichert W, Kopka K, Debus J, Haberkorn U. The diagnostic value of PET/CT imaging with the (68)Ga-labelled PSMA ligand HBED-CC in the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2015 Feb;42(2):197-209. doi: 10.1007/s00259-014-2949-6. Epub 2014 Nov 20. PMID 25411132
- BACKGROUNDGreen MA, Eitel JA, Fletcher JW, Mathias CJ, Tann MA, Gardner T, Koch MO, Territo W, Polson H, Hutchins GD. Estimation of radiation dosimetry for 68Ga-HBED-CC (PSMA-11) in patients with suspected recurrence of prostate cancer. Nucl Med Biol. 2017 Mar;46:32-35. doi: 10.1016/j.nucmedbio.2016.11.002. Epub 2016 Nov 4. PMID 28012435