Clinical trial · Interventional
Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy
68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy
NCT02940262CI-TRIAL-00052529completedPhase 3ClinicalTrials.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 clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) works in detecting prostate cancer that has come back (recurrent) in patients after initial therapy. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT, may help doctors detect tumors that have come back after initial therapy.
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium Ga 68 Gozetotide | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (68Ga-PSMA-11)
- description
- Patients receive gallium Ga 68-labeled PSMA-11 IV. Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.
- interventionNames
- Radiation: Gallium Ga 68 Gozetotide
- Other: Laboratory Biomarker Analysis
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location
- timeFrame
- Up to 12 months
- description
- Confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria:
* Histopathological proven prostate adenocarcinoma
* Rising PSA after definitive therapy with prostatectomy or radiation therapy.
* Post radical prostatectomy (RP)
* PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
* Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition
* Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/ World Health Organization \[WHO\] equivalent)
* Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria:
* Concomitant investigational therapy
* Known inability to lie flat, remain still or tolerate a PET scan
* Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancerReferences
Publications (6)
- DERIVEDNikitas J, Smith CP, Armstrong WR, Murthy V, Grogan T, Clark K, Moore J, Roberts M, Farolfi A, Reiter RE, Rettig MB, Shen J, Valle LF, Nickols NG, Steinberg ML, Czernin J, Kishan AU, Calais J. Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy. J Natl Compr Canc Netw. 2026 Feb;24(2):11-18. doi: 10.6004/jnccn.2025.7102. PMID 41698328
- DERIVEDFendler WP, Calais J, Eiber M, Simko JP, Kurhanewicz J, Santos RD, Feng FY, Reiter RE, Rettig MB, Nickols NG, Kishan AU; PSMA PET Reader Group; Slavik R, Carroll PR, Lawhn-Heath C, Herrmann K, Czernin J, Hope TA. False positive PSMA PET for tumor remnants in the irradiated prostate and other interpretation pitfalls in a prospective multi-center trial. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):501-508. doi: 10.1007/s00259-020-04945-1. Epub 2020 Aug 17. PMID 32808077
- DERIVEDCalais J, Ceci F, Eiber M, Hope TA, Hofman MS, Rischpler C, Bach-Gansmo T, Nanni C, Savir-Baruch B, Elashoff D, Grogan T, Dahlbom M, Slavik R, Gartmann J, Nguyen K, Lok V, Jadvar H, Kishan AU, Rettig MB, Reiter RE, Fendler WP, Czernin J. 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. Lancet Oncol. 2019 Sep;20(9):1286-1294. doi: 10.1016/S1470-2045(19)30415-2. Epub 2019 Jul 30. PMID 31375469
- DERIVEDFendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096. PMID 30920593
- DERIVEDCalais J, Fendler WP, Herrmann K, Eiber M, Ceci F. Comparison of 68Ga-PSMA-11 and 18F-Fluciclovine PET/CT in a Case Series of 10 Patients with Prostate Cancer Recurrence. J Nucl Med. 2018 May;59(5):789-794. doi: 10.2967/jnumed.117.203257. Epub 2017 Dec 14.