RRPC Axumin PETMRI

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05035732
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6.9
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

This study will 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostate Nodule	Radiation: 18F-fluciclovine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
• Anticipated Study Start Date: Sep 30, 2022
• Anticipated Primary Completion Date: Apr 28, 2023
• Anticipated Study Completion Date: Apr 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 18F-ACBC	Radiation: 18F-fluciclovine; IV

Outcome Measures

Primary Outcome Measures

1. To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Devaki S Surasi, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05035732
• Other Study ID Numbers: 2021-0146
• First Posted: Sep 5, 2021
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Feb 16, 2022