Trial Outcomes & Findings for Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI (NCT NCT03264456)

NCT ID: NCT03264456

Last Updated: 2020-03-09

Results Overview

Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Baseline through 24 hr

Results posted on

2020-03-09

Participant Flow

Three consented patients chose not to undergo the initial PET/MRI scan prior to the scan being performed. Additionally, one patient's images were lost to data corruption and the patient was not included in the final analysis.

Participant milestones

Participant milestones
Measure	[18F] Fluciclovine PET/MRI \[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer \[18F\] Fluciclovine PET/MRI: \[18F\] fluciclovine PET/MRI \[18F\] fluciclovine: \[18F\] fluciclovine
Overall Study STARTED	18
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	[18F] Fluciclovine PET/MRI \[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer \[18F\] Fluciclovine PET/MRI: \[18F\] fluciclovine PET/MRI \[18F\] fluciclovine: \[18F\] fluciclovine
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	1

Baseline Characteristics

Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	[18F] Fluciclovine PET/MRI n=14 Participants \[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer \[18F\] Fluciclovine PET/MRI: \[18F\] fluciclovine PET/MRI \[18F\] fluciclovine: \[18F\] fluciclovine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	65.6 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 24 hr

Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI

Outcome measures

Outcome measures
Measure	[18F] Fluciclovine PET/MRI n=14 Participants \[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer \[18F\] Fluciclovine PET/MRI: \[18F\] fluciclovine PET/MRI \[18F\] fluciclovine: \[18F\] fluciclovine
Number of Patients With Primary Lesions Detected	14 Participants

PRIMARY outcome

Timeframe: Baseline through 24 hours

Number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI

Outcome measures

Outcome measures
Measure	[18F] Fluciclovine PET/MRI n=14 Participants \[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer \[18F\] Fluciclovine PET/MRI: \[18F\] fluciclovine PET/MRI \[18F\] fluciclovine: \[18F\] fluciclovine
Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI	7 Participants

SECONDARY outcome

Timeframe: Baseline through 24 hours

Population: Total number of patients who demonstrated nodal metastatic disease on fluciclovine-PET/MRI

Compare number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.

Outcome measures

Outcome measures
Measure	[18F] Fluciclovine PET/MRI n=7 Participants \[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer \[18F\] Fluciclovine PET/MRI: \[18F\] fluciclovine PET/MRI \[18F\] fluciclovine: \[18F\] fluciclovine
Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI PET/MRI	7 Participants
Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI MR alone	3 Participants

SECONDARY outcome

Timeframe: Baseline through 8 weeks

Population: Number of patients in total cohort who underwent ADT

Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)

Outcome measures

Outcome measures
Measure	[18F] Fluciclovine PET/MRI n=10 Participants \[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer \[18F\] Fluciclovine PET/MRI: \[18F\] fluciclovine PET/MRI \[18F\] fluciclovine: \[18F\] fluciclovine
Follow-up Pretreatment maximum SUV	7.1 standardized uptake values Standard Deviation 1.7
Follow-up Maximum SUV after 8 weeks of ADT	3.5 standardized uptake values Standard Deviation 2.0

Adverse Events

[18F] Fluciclovine PET/MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samuel Galgano

University of Alabama at Birmingham

Phone: 2059341388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60