Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

Primary Objective:

• To determine whether changes in uptake of [18F]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.

Secondary Objectives:

• To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with overall survival (OS)

• To determine whether baseline SUVmax correlate with rPFS

• To compare number of lesions detected with standard imaging at baseline and at the time of progression

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emerson Lim

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of prostate cancer

• Age ≥ 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

• Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3

• Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease

• Ability to understand and willingness to sign a written informed consent document

• Wiling to comply with clinical trial instructions and requirements

Exclusion Criteria:

• History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin

• Presence of prostate brachytherapy implants

• Administration of another radioisotope within five physical half-lives of trial enrollment

• Radiation or chemotherapy within 2 weeks prior to trial enrollment

• Serum creatinine > 3 times the upper limit of normal

• Serum total bilirubin > 3 times the upper limit of normal

• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper limit of normal

• Inadequate venous access