PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.

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

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Prostate cancer pathologically proven by prostate biopsy

• Two consecutive rising PSA value

• Total testosterone < 50 ng/dL

• imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities

Exclusion Criteria:

• Radiation therapy or start of standard of care systemic therapy (chemotherapy, androgen deprivation therapy) within 14 days prior to study PET

• Investigational therapy for prostate cancer less than 28 days prior to study PET imaging.

• Unable to lie flat during or tolerate PET/CT

• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

• Serum creatinine > 3 times the upper limit of normal

• Total bilirubin > 3 times the upper limit of normal

• Liver Transaminases > 5times the upper limit of normal