NCT03996993

Defining Recurrent Disease With Axumin™

Diagnosing and Monitoring Recurrent Disease in Prostate Cancer Patients Using a Positron Emission Tomography Radiotracer (Axumin™)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Cancer Center of Irvine · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This project seeks to use advanced imaging (specifically, positron emission tomography/computed tomography \[PET/CT\]) to detect, locate, and characterize recurrent disease in the setting of patients with prostate cancer.

Detailed description

This protocol details the study design for patients with prostate cancer (PCa) who have failed primary treatment with radical prostatectomy, and now have rising PSA as indicated by a recent PSA blood draw value \> 0.1 ng/ml. Patients fitting our inclusion criteria for the study, will receive an Axumin scan as part of their standard of care (SOC) treatment. If the SOC scan is positive, patients under this protocol will either subsequently receive hormone therapy OR salvage radiation therapy (not both concurrently). Patient response to therapy will be assessed with serial Axumin scans identifying additional lesions present at 3 months, 6 months, and 12 months (1 year) post-therapy, with the latter time point being our endpoint of the study. The study aims are as follows: 1. The investigators would like to understand the hormonal therapy response based on Axumin scans administered over a time course of 3 months, 6 months, and 12 months post-hormone therapy treatment. 2. The investigators would like to understand the salvage radiotherapy response based on Axumin scan results incorporated into radiation treatment planning over a time course of 3 months, 6 months, and 12 months post-salvage radiation treatment.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Casodex, Axumin	Patients will receive hormone therapy if Axumin positive area appears.
RADIATION	Salvage Radiation, Axumin	Patients will receive salvage radiation therapy if Axumin positive area appears.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-09-30
• Completion: 2020-12-30
• First posted: 2019-06-25
• Last updated: 2019-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study