Trial Outcomes & Findings for FACBC for Recurrent Prostate Cancer (NCT NCT01808222)

Last Updated: 2019-01-07

Results Overview

Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where: 1. = definitely benign 2. = probably benign 3. = equivocal 4. = probably malignant 5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Up to 43 months

Results posted on

2019-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	FACBC Participants receiving a bolus of anti-\[18F\]FACBC injected with positron emission tomography (PET)-computerized tomography (CT) (PET-CT) and a multiparametric MRI (mpMR) for detection of cancer recurrence.
Overall Study STARTED	25
Overall Study Completed Fluciclovine PET-CT Scan	25
Overall Study Completed mpMR Scan	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	FACBC Participants receiving a bolus of anti-\[18F\]FACBC injected with positron emission tomography (PET)-computerized tomography (CT) (PET-CT) and a multiparametric MRI (mpMR) for detection of cancer recurrence.
Overall Study mpMR scan was not performed	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FACBC n=24 Participants Participants receiving a bolus of anti-\[18F\]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence.
Age, Continuous	70.8 years STANDARD_DEVIATION 5.7 • n=24 Participants
Sex: Female, Male Female	0 Participants n=24 Participants
Sex: Female, Male Male	24 Participants n=24 Participants
Region of Enrollment United States	24 participants n=24 Participants
PET-MR Interval	7.5 days n=24 Participants
Prior prostate cancer therapy Brachytherapy alone	3 Participants n=24 Participants
Prior prostate cancer therapy Brachytherapy with one	8 Participants n=24 Participants
Prior prostate cancer therapy Brachytherapy as part of 3+ treatments	5 Participants n=24 Participants
Prior prostate cancer therapy Radiotherapy alone	3 Participants n=24 Participants
Prior prostate cancer therapy 3+ Other Treatment Modalities	2 Participants n=24 Participants
Prior prostate cancer therapy Proton Therapy	1 Participants n=24 Participants
Prior prostate cancer therapy Cryotherapy alone	1 Participants n=24 Participants
Prior prostate cancer therapy Cryotherapy plus hormonal therapy	1 Participants n=24 Participants
Prostate-Specific Antigen (PSA)	8.5 Nanograms per milliliter (ng/ml) STANDARD_DEVIATION 6.1 • n=24 Participants

PRIMARY outcome

Timeframe: Up to 43 months

Population: The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (22 out of 24 participants who received both scans). The remaining two had no biopsy or had insufficient follow-up information to reach a consensus about disease status.

Outcome measures

Outcome measures
Measure	FACBC n=22 Participants Participants receiving a bolus of anti-\[18F\]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence.
The Presence of Cancer Tissue Inside of the Prostate Bed PET-CT Readers 1 and 2 · True Positivies	13 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed PET-CT Readers 1 and 2 · False Positives	8 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed PET-CT Readers 1 and 2 · True Negatives	1 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed PET-CT Readers 1 and 2 · False Negatives	0 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed mpMR Reader 1 · True Positivies	5 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed mpMR Reader 1 · False Positives	4 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed mpMR Reader 1 · True Negatives	5 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed mpMR Reader 1 · False Negatives	8 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed mpMR Reader 2 · True Positivies	2 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed mpMR Reader 2 · False Positives	2 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed mpMR Reader 2 · True Negatives	7 Participants
The Presence of Cancer Tissue Inside of the Prostate Bed mpMR Reader 2 · False Negatives	11 Participants

PRIMARY outcome

Timeframe: Up to 43 months

Population: The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (18 out of 24 participants who received both scans).

Outcome measures

Outcome measures
Measure	FACBC n=18 Participants Participants receiving a bolus of anti-\[18F\]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence.
The Presence of Cancer Tissue Outside of the Prostate Bed PET-CT Readers 1 and 2 · True Positives	7 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed PET-CT Readers 1 and 2 · False Positives	1 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed PET-CT Readers 1 and 2 · True Negatives	9 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed PET-CT Readers 1 and 2 · False Negatives	1 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed mpMR Reader 1 · True Positives	4 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed mpMR Reader 1 · False Positives	3 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed mpMR Reader 1 · True Negatives	7 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed mpMR Reader 1 · False Negatives	4 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed mpMR Reader 2 · True Positives	6 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed mpMR Reader 2 · False Positives	2 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed mpMR Reader 2 · True Negatives	8 Participants
The Presence of Cancer Tissue Outside of the Prostate Bed mpMR Reader 2 · False Negatives	2 Participants

Adverse Events

FACBC

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

David Schuster MD

Emory University

Phone: 404-712-4859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place