Clinical trial · Interventional
Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer
Clinical Accuracy Assessment of 68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence
NCT03822845CI-TRIAL-00088655completedPhase 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 (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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| 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/CT scan
- interventionNames
- Drug: Ga-68 PSMA-HBED-CC PET
Primary outcomes (1)
- measure
- Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection on a Per Patient Basis
- timeFrame
- Up to 12 months after the 68Ga PSMA PET scan
- description
- Sensitivity was defined as the proportion of subjects correctly identified as positive by Ga-68 PSMA-11 PET/CT scans compared to a reference standard. Reference standards included conventional imaging (CT, MRI), clinical follow-up within 12 months after PET, and histopathology/biopsy when available. A true positive was defined as a lesion detected by Ga-68 PSMA PET/CT and confirmed by at least one reference standard.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Ability to understand and willingness to provide informed consent.
* Pathologically proven prostate adenocarcinoma.
* Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).
* If post-radical prostatectomy, a PSA level of \> 0.2 ng/mL measured more than 6 weeks post-operatively with a second confirmatory persistent PSA \> 0.2 ng/mL.
* If post-radiation therapy, a PSA level that is equal to, or greater than, a 2 mg/mL rise above the lowest PSA value ('nadir').
* A PSA level result within the last 2 months meeting criteria above.
* Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations).
* No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).
* Karnofsky performance status greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months.
Exclusion Criteria:
* Cannot receive furosemide.
* History of Stevens-Johnson syndrome.
* History or diagnosis of Paget's disease.
* Malignancy other than current disease under study.
* Allergy to sulfa or sulfa-containing medications.
* 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