Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer
NCT ID: NCT04279561
Last Updated: 2022-09-21
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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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2020-04-16
2022-09-15
Brief Summary
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Detailed Description
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I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI).
SECONDARY OBJECTIVES:
I. To correlate PSMA imaging changes with prostate specific antigen (PSA) kinetics.
II. To correlate PSMA imaging changes with progression free survival. III. To evaluate the changes in PSMA PET staging (miTNM Prostate Cancer Molecular Imaging Standardized Evaluation \[PROMISE\] criteria) under ARSI.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) intravenously (IV). After 50-100 minutes, patients undergo positron emission tomography (PET)/computed tomography (CT) over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (68GA-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
Computed Tomography
Undergo 68Ga-PSMA-11 PET/CT
Gallium Ga 68 Gozetotide
Given IV
Positron Emission Tomography
Undergo 68Ga-PSMA-11 PET/CT
Interventions
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Computed Tomography
Undergo 68Ga-PSMA-11 PET/CT
Gallium Ga 68 Gozetotide
Given IV
Positron Emission Tomography
Undergo 68Ga-PSMA-11 PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Know metastatic disease on previous imaging, or PSA value ⩾ 1 ng/ml;
* Castration resistant disease with confirmed testosterone level =\< 50 ng/ml under prior first-line androgen deprivation therapy (ADT)
* New planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide
* Willingness to undergo ARSI throughout the duration of the study as prescribed by the treating uro-oncologist
* Stated willingness to comply with continuation of ARSI treatment for the duration of the study
* Provision of signed and dated informed consent form
Exclusion Criteria
* Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
* Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
* A baseline superscan pattern on bone scan
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible
18 Years
MALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jeremie Calais
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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Sonni I, Gafita A, Unterrainer LM, Alano RM, Lira S, Shen J, Drakaki A, Grogan T, Rettig MB, Czernin J, Calais J. Effects of novel androgen receptor signaling inhibitors on PSMA PET signal intensity in patients with castrate-resistant prostate cancer: a prospective exploratory serial imaging study. EJNMMI Res. 2023 Oct 30;13(1):95. doi: 10.1186/s13550-023-01048-4.
Other Identifiers
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NCI-2020-00239
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-002024
Identifier Type: -
Identifier Source: org_study_id
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