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

NCT03585114 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAR6032
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS)

  To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.

  Baseline, Post-treatment (approximately 6 weeks)

Secondary Outcomes (3)

• Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS)

  Baseline, Post-treatment (approximately 6 weeks)

• Prevalence of baseline SUVmax correlating with rPFS

  Baseline, Post-treatment (approximately 6 weeks)

• Change in number of lesions detected with standard imaging at baseline and at the time of progression

  Baseline, up to 1 year

Study Arms (1)

PyL-PET

EXPERIMENTAL

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.

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

Interventions

[F-18] DCFPyL DRUG

\[18F\]DCFPyL will be used for study imaging. It will be administered intravenously on the day of imaging. Subjects will receive a bolus injection of 9mCi (331 MBq) of \[18F\]DCFPyL through a peripheral IV catheter. 60 to 120 minutes after injection, a whole body (toes to vertex) lowdose CT will be obtained (120 kVp, 80 mA maximum).

Also known as: [18F]DCFPyL (PyL)

PyL-PET

PET/CT imaging PROCEDURE

As per standard of care, acquisition will be performed on PET/CT scanner (Siemens, Germany) operating in 3D emission mode with CT-derived attenuation correction.

Also known as: PET/CT acquisition

PyL-PET

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

• Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

  PMID: 28055103 BACKGROUND

• Szabo Z, Mena E, Rowe SP, Plyku D, Nidal R, Eisenberger MA, Antonarakis ES, Fan H, Dannals RF, Chen Y, Mease RC, Vranesic M, Bhatnagar A, Sgouros G, Cho SY, Pomper MG. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):565-74. doi: 10.1007/s11307-015-0850-8.

  PMID: 25896814 BACKGROUND

• Rowe SP, Macura KJ, Mena E, Blackford AL, Nadal R, Antonarakis ES, Eisenberger M, Carducci M, Fan H, Dannals RF, Chen Y, Mease RC, Szabo Z, Pomper MG, Cho SY. PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Mol Imaging Biol. 2016 Jun;18(3):411-9. doi: 10.1007/s11307-016-0957-6.

  PMID: 27080322 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Matthew C. Dallos, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Fifteen men will be recruited from Columbia University Medical Center.

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: December 11, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)