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

Primary Purpose

Metastatic Prostate Cancer

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[F-18] DCFPyL

PET/CT imaging

About this trial

This is an interventional treatment trial for Metastatic Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PyL-PET

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The percent difference in summed SUV between the first and second PET/CT will be noted.

Prevalence of baseline SUVmax correlating with rPFS

To determine if standardized uptake values (SUVs) at baseline is a good measure for patient evaluation.

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

To compare lesions detected with standard imaging

Full Information

NCT ID

NCT03585114

First Posted

June 29, 2018

Last Updated

May 6, 2022

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT03585114

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 11, 2018 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Fifteen men will be recruited from Columbia University Medical Center.

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PyL-PET

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

[F-18] DCFPyL

Other Intervention Name(s)

[18F]DCFPyL (PyL)

Intervention Description

[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).

Intervention Type

Procedure

Intervention Name(s)

PET/CT imaging

Other Intervention Name(s)

PET/CT acquisition

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline, Post-treatment (approximately 6 weeks)

Secondary Outcome Measure Information:

Title

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

Description

The percent difference in summed SUV between the first and second PET/CT will be noted.

Time Frame

Baseline, Post-treatment (approximately 6 weeks)

Title

Prevalence of baseline SUVmax correlating with rPFS

Description

To determine if standardized uptake values (SUVs) at baseline is a good measure for patient evaluation.

Time Frame

Baseline, Post-treatment (approximately 6 weeks)

Title

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

Description

To compare lesions detected with standard imaging

Time Frame

Baseline, up to 1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew C. Dallos, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28055103

Citation

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.

Results Reference

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PubMed Identifier

25896814

Citation

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.

Results Reference

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PubMed Identifier

27080322

Citation

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.

Results Reference

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

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