Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy
NCT ID: NCT02940262
Last Updated: 2021-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1138 participants
INTERVENTIONAL
2016-09-15
2021-06-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Treatment (68Ga-PSMA-11)
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.
Gallium Ga 68 Gozetotide
Given IV
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo PET imaging
Interventions
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Gallium Ga 68 Gozetotide
Given IV
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo PET imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 cancer
MALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Johannes Czernin, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NCI-2016-01212
Identifier Type: REGISTRY
Identifier Source: secondary_id
16-001095
Identifier Type: -
Identifier Source: org_study_id
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