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Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT

Primary Purpose

Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-fluciclovine
PET/CT
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Advanced Prostate Cancer focused on measuring Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma, PSMA-Low Castration Resistant Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria: Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET/CT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma/NE features and/or IHC staining for NE markers. Participants should have at least 5 metastatic lesions. Must have either already had standard of care 68Ga-PSMA PET/CT scan or be planned for 68Ga-PSMA PET/CT scan before or after the planned 18F-fluciclovine-PET/CT. Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) Ability and willingness to comply with the study procedures. The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is completed. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Participants with other known malignancy requiring treatment History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Contraindications for PET/CT including: Severe claustrophobia Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study.

Sites / Locations

  • Dana Farber Cancer Institute
  • Brigham and Womens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-fluciclovine

Arm Description

Participants with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine prostate cancer will receive: 18F-fluciclovine PET/CT within 6 weeks of standard of care exam and 68Ga-PSMA PET/CT 2x Blood test at time of 18F-fluciclovine PET/CT and prior to treatment as determined by participants primary oncologist

Outcomes

Primary Outcome Measures

Fluciclovine and PSMA Uptake in PSMA Positive Tumors
Number of 18F-fluciclovine positive lesions in PSMA-positive tumors on PET Number of fluciclovine positive tumors that are PSMA-negative
Fluciclovine and PSMA Uptake in PSMA Negative Tumors
Number of 18F-fluciclovine positive lesions in PSMA-negative tumors on PET

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 25, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Blue Earth Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT06062745
Brief Title
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Official Title
A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET/CT Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Blue Earth Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features. The name of the study interventions are: 18F-fluciclovine-PET/CT scan Two research blood collections
Detailed Description
This research study is a pilot study, which is the first-time investigators are examining this study imaging agent, 18F-fluciclovine, for use in PSMA-low castration resistant and neuroendocrine prostate cancer detection. 18F-fluciclovine is approved by the U.S. Food and Drug Administration (FDA). It is approved for imaging the early stages of prostate cancer. It is not approved for imaging PSMA-low castration resistant or neuroendocrine prostate cancer. 18F-fluciclovine is a radiotracer for PET imaging that targets amino-acid receptors. Some information shows that both PSMA-low and neuroendocrine prostate tumors use amino acids for energy. The purpose of this study to determine if PSMA-low and neuroendocrine prostate cancer can be seen with 18F-fluciclovine-PET/CT. Secondary aims are better understanding of the role of amino acids and PSMA in PSMA low and neuroendocrine prostate cancer and how imaging tests can be used together to optimize treatments for PSMA-low and neuroendocrine prostate cancer. Participants will receive a PSMA-PET/CT as part standard of care and as part of the study receive 18F-fluciclovine-PET/CT scan along with two research blood collections. Blue Earth Diagnostics Inc. is supporting this research study by providing the 18Ffluciclovine and funding for the research study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma
Keywords
Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma, PSMA-Low Castration Resistant Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-fluciclovine
Arm Type
Experimental
Arm Description
Participants with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine prostate cancer will receive: 18F-fluciclovine PET/CT within 6 weeks of standard of care exam and 68Ga-PSMA PET/CT 2x Blood test at time of 18F-fluciclovine PET/CT and prior to treatment as determined by participants primary oncologist
Intervention Type
Drug
Intervention Name(s)
18F-fluciclovine
Other Intervention Name(s)
Axumin
Intervention Description
18F-fluciclovine is a radiotracer targeting amino-acid transporters.Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance to make images of processes that are happening in the body
Intervention Type
Device
Intervention Name(s)
PET/CT
Intervention Description
Positron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.
Primary Outcome Measure Information:
Title
Fluciclovine and PSMA Uptake in PSMA Positive Tumors
Description
Number of 18F-fluciclovine positive lesions in PSMA-positive tumors on PET Number of fluciclovine positive tumors that are PSMA-negative
Time Frame
Up to 6 months
Title
Fluciclovine and PSMA Uptake in PSMA Negative Tumors
Description
Number of 18F-fluciclovine positive lesions in PSMA-negative tumors on PET
Time Frame
up to 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET/CT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma/NE features and/or IHC staining for NE markers. Participants should have at least 5 metastatic lesions. Must have either already had standard of care 68Ga-PSMA PET/CT scan or be planned for 68Ga-PSMA PET/CT scan before or after the planned 18F-fluciclovine-PET/CT. Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) Ability and willingness to comply with the study procedures. The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is completed. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Participants with other known malignancy requiring treatment History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Contraindications for PET/CT including: Severe claustrophobia Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Jacene, MD
Phone
617-632-3767
Email
hjacene@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Jacene, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Jacene, MD
Phone
617-632-3767
Email
hjacene@partners.org
First Name & Middle Initial & Last Name & Degree
Heather Jacene, MD
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather A Jacene, MD
Phone
617-632-3767
Email
hjacene@partners.org
First Name & Middle Initial & Last Name & Degree
Heather A Jacene, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT

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