Status:
TERMINATED
Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE1
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...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI). SECONDARY OBJECTIVES: ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04279561
Start Date
April 16 2020
End Date
September 15 2022
Last Update
September 21 2022
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095