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Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer

About

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.

Primary Purpose
Diagnostic
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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 Criteria:

  • 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

Join this Trial

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Study Stats
Protocol No.
19-002024
Category
Molecular & Medical Pharmacology
Oncology
Principal Investigator
JEREMIE CALAIS
Contact
JEREMIE CALAIS
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04279561
For detailed technical eligibility, visit ClinicalTrials.gov.