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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01212 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
PRIMARY OBJECTIVE:
I. To assess the sensitivity on a per-patient and per-region-basis of Gallium Ga 68 Gozetotide (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
SECONDARY OBJECTIVES:
I. To assess the positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up (composite reference standard).
II. To assess the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy only.
III. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0).
IV. To assess the impact of 68Ga-PSMA-11 PET on clinical management in biochemical recurrence (BCR) patients.
V. To assess the inter-reader reproducibility. VI. To assess the safety of 68Ga-PSMA-11 PET. VII. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA velocity and PSA doubling-time.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.
After completion of study, patients are followed up for 3-12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (68Ga-PSMA-11) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gallium Ga 68 Gozetotide | Radiation | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive value (PPV) on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location | Confirmed by histopathology/biopsy and, clinical and conventional imaging follow-up. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The paired McNemar's test will be used to compare the positive predictive values of gallium Ga 68-labeled PSMA-11 positron emission tomography imaging to the positive predictive values of conventional imaging. |
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Inclusion Criteria:
Histopathological proven prostate adenocarcinoma
Rising PSA after definitive therapy with prostatectomy or radiation therapy.
Post radical prostatectomy (RP)
Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition
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:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Czernin, MD | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41698328 | Derived | Nikitas 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. | |
| 32808077 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2023 | |
| Reset | Jul 6, 2023 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Positron Emission Tomography | Procedure | Undergo PET imaging |
|
|
| Up to 12 months |
| Sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 positron emission tomography (PET) for detection of tumor location confirmed by histopathology/biopsy | Will be summarized in tabular format. Ninety-five confidence intervals of sensitivity, specificity, and net present value (NPV) will be calculated using the Wilson score method. | Up to 12 months |
| Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value | Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0) and PSA velocity/doubling-time will be summarized in tabular format and compared between PSA strata using chi-square analysis. | Up to 12 months |
| Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA velocity and PSA doubling-time | Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0) and PSA velocity/doubling-time will be summarized in tabular format and compared between PSA strata using chi-square analysis. | Up to 12 months |
| Clinical management in biochemical recurrence patients | The impact of gallium Ga 68-labeled PSMA-11 positron emission tomography on clinical management in biochemical recurrence patients will be evaluated using descriptive statistics. | Up to 12 months |
| Inter-reader reproducibility | Inter-reader reproducibility for positivity at the patient level and region level will be reported using the Fleiss' Kappa test for multiple readers. | Up to 12 months |
| Incidence of adverse events | Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events 4.03. | Up to 12 months |
| Derived |
| Fendler 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. |
| 31375469 | Derived | Calais 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. |
| 30920593 | Derived | Fendler 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. |
| 29242404 | Derived | Calais 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. |
| 29242398 | Derived | Calais J, Fendler WP, Eiber M, Gartmann J, Chu FI, Nickols NG, Reiter RE, Rettig MB, Marks LS, Ahlering TE, Huynh LM, Slavik R, Gupta P, Quon A, Allen-Auerbach MS, Czernin J, Herrmann K. Impact of 68Ga-PSMA-11 PET/CT on the Management of Prostate Cancer Patients with Biochemical Recurrence. J Nucl Med. 2018 Mar;59(3):434-441. doi: 10.2967/jnumed.117.202945. Epub 2017 Dec 14. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2023 | Jul 6, 2023 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| C000622699 | 68Ga-DKFZ-PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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