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

• Status: Recruiting
• Trial end date: 2023-06-15
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Androgens; Edetic Acid; Gallium 68 PSMA-11

Criteria

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