Study Stopped
slow accrual
Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer
Effects of Novel Androgen Receptor Signaling Inhibitors on PSMA PET Signal Intensity in Patients With Castrate-Resistant Prostate Cancer: A Prospective Exploratory Study
2 other identifiers
interventional
9
1 country
1
Brief Summary
This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedStudy Start
First participant enrolled
April 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedSeptember 21, 2022
September 1, 2022
2.4 years
February 19, 2020
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in 68Ga-PSMA-11 lesion and total-body uptake (standardized uptake value [SUV]max and SUVmean) over time in response to androgen receptor signaling inhibitors (ARSI)
Changes are expressed in terms of percentage changes from baseline positron emission tomography (PET) (before ARSI). Will utilize mixed effect regression models to evaluate the change over time in PSMA results.
Baseline, assessed up to 1 year
Secondary Outcomes (5)
Prostate specific antigen (PSA) kinetics under ARSI
Baseline, assessed up to 1 year
Biochemical progression free survival (bPFS)
Up to 1 year
Changes in lesion size on cross sectional imaging under ARSI
Up to 1 year
Changes in staging (PSMA miTNM PROMISE criteria) under ARSI
Up to 1 year
Incidence of adverse events
Up to 1 year
Study Arms (1)
Diagnostic (68GA-PSMA-11 PET/CT)
EXPERIMENTALPatients 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).
Interventions
Undergo 68Ga-PSMA-11 PET/CT
Given IV
Undergo 68Ga-PSMA-11 PET/CT
Eligibility Criteria
You may qualify if:
- Histologically proven prostate cancer
- 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
You may not qualify if:
- Inability to provide written informed consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Related Publications (1)
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.
PMID: 37902861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremie Calais
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2020
First Posted
February 21, 2020
Study Start
April 16, 2020
Primary Completion
September 15, 2022
Study Completion
September 15, 2022
Last Updated
September 21, 2022
Record last verified: 2022-09