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A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)

Primary Purpose

Prostate Cancer, Prostate Nodule

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
18F-fluciclovine
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male patients who are 18 years and older
  2. Histologically or cytologically proven prostate carcinoma s/p definitive radiation
  3. Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir)
  4. Ability to understand and willingness to sign informed consent

Exclusion Criteria:

  1. Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
  2. Patients with contraindication to undergo MRI
  3. Patients with prior allergy to MRI contrast agent.
  4. Extreme Claustrophobia

Sites / Locations

  • The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-ACBC

Arm Description

Outcomes

Primary Outcome Measures

To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI

Secondary Outcome Measures

Full Information

First Posted
August 24, 2021
Last Updated
August 31, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05035732
Brief Title
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
Official Title
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 28, 2024 (Anticipated)
Primary Completion Date
April 28, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.
Detailed Description
Primary Objective: --To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard. Secondary Objective: --To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers. Exploratory Objective: --To study correlation between SUVmax and ADCmean in the pelvic RRPC.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-ACBC
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
18F-fluciclovine
Intervention Description
IV
Primary Outcome Measure Information:
Title
To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male patients who are 18 years and older Histologically or cytologically proven prostate carcinoma s/p definitive radiation Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir) Ability to understand and willingness to sign informed consent Exclusion Criteria: Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements. Patients with contraindication to undergo MRI Patients with prior allergy to MRI contrast agent. Extreme Claustrophobia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Devaki S Surasi
Phone
713-792-6536
Email
dssurasi@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devaki S Surasi
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devaki Surasi, MD
Phone
713-792-6536
Email
dssurasi@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Devaki Surasi, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)

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