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

Columbia University

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Prostate Cancer

Treatments: Procedure: PET/CT imaging; Drug: [F-18] DCFPyL

Study type: Interventional

Funder types: Other

Identifiers

NCT03585114

AAAR6032

Details and patient eligibility

About

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

Full description

Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.

PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Enrollment: 11 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

PyL-PET

Experimental group

Description:

Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive \[F-18\] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.

Treatment:

Drug: [F-18] DCFPyL

Procedure: PET/CT imaging