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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03264456
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 27.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

There is great need for improved preoperative imaging in men with high-risk prostate cancer. Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently problematic. Conventional imaging is falsely negative for regional lymph node metastases in a substantial fraction of men. In particular, approximately 35% of men with high-risk prostate cancer will have biochemical recurrence even after optimal surgical resection. A major benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18 fluciclovine PET includes having the patient undergo a single imaging study which provides both anatomic and molecular characterization of the tumor, including metastases which would potentially be missed by conventional anatomic imaging and size criteria. Additionally, simultaneous acquisition will improve co-registration of the PET and MR data which is valuable for small lesions and in anatomically complex regions. Although the use of fluciclovine in the characterization of the primary PCa remains to be established, the anatomic detail provided by conventional mpMRI will complement the detection of small volume metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology allows for the assessment of dynamic tracer uptake and washout during the whole body and regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology to develop new treatment algorithms for the optimal management of these patients.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: [18F] Fluciclovine PET/MRI; Drug: [18F] fluciclovine	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
• Actual Study Start Date: Nov 8, 2017
• Actual Primary Completion Date: Jan 30, 2019
• Actual Study Completion Date: Feb 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [18F] Fluciclovine PET/MRI [18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer	Diagnostic Test: [18F] Fluciclovine PET/MRI; [18F] fluciclovine PET/MRI; Drug: [18F] fluciclovine; [18F] fluciclovine

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Primary Lesions Detected [Baseline through 24 hr]

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

2. Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI [Baseline through 24 hours]

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

Secondary Outcome Measures

1. Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI [Baseline through 24 hours]

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

2. Follow-up [Baseline through 8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or serum PSA > 20)

Exclusion Criteria:

• Inability to tolerate or undergo PET/MRI

• Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)

• Recurrent prostate adenocarcinoma

• Known visceral, osseous, or extrapelvic metastases prior to fluciclovine-PET/MRI

• Known allergy to glucagon or gadolinium-based contrast

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Medical Center	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Samuel Galgano, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 11, 2019

More Information

Publications

None provided.

• Responsible Party: Samuel Joseph Galgano, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03264456
• Other Study ID Numbers: IRB-300000291
• First Posted: Aug 29, 2017
• Last Update Posted: Mar 9, 2020
• Last Verified: Feb 1, 2020

• 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.: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	[18F] Fluciclovine PET/MRI
Arm/Group Description	[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer [18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI [18F] fluciclovine: [18F] fluciclovine
Period Title: Overall Study
STARTED	18
COMPLETED	14
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	[18F] Fluciclovine PET/MRI
Arm/Group Description	[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 Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 57.1%
>=65 years	6 42.9%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	65.6
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	14 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 50%
White	7 50%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Primary Lesions Detected
Description	Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI
Time Frame	Baseline through 24 hr

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	[18F] Fluciclovine PET/MRI
Arm/Group Description	[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer [18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI [18F] fluciclovine: [18F] fluciclovine
Measure Participants	14
Count of Participants [Participants]	14 100%

2. Primary Outcome

Title	Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI
Description	Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI
Time Frame	Baseline through 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	[18F] Fluciclovine PET/MRI
Arm/Group Description	[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer [18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI [18F] fluciclovine: [18F] fluciclovine
Measure Participants	14
Count of Participants [Participants]	7 50%

3. Secondary Outcome

Title	Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI
Description	Compare number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.
Time Frame	Baseline through 24 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	[18F] Fluciclovine PET/MRI
Arm/Group Description	[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer [18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI [18F] fluciclovine: [18F] fluciclovine
Measure Participants	7
MR alone	3 21.4%
PET/MRI	7 50%

4. Secondary Outcome

Title	Follow-up
Description	Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)
Time Frame	Baseline through 8 weeks

Outcome Measure Data

Analysis Population Description

Number of patients in total cohort who underwent ADT

Arm/Group Title	[18F] Fluciclovine PET/MRI
Arm/Group Description	[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer [18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI [18F] fluciclovine: [18F] fluciclovine
Measure Participants	10
Pretreatment maximum SUV	7.1 (1.7)
Maximum SUV after 8 weeks of ADT	3.5 (2.0)

Adverse Events

Time Frame	Baseline through 8 week follow-up scan
Adverse Event Reporting Description	Given that fluciclovine is a FDA clinically approved radiotracer with almost no risk of serious adverse events and all cause mortality, the expected risk of these in this study is effectively 0.
Arm/Group Title	[18F] Fluciclovine PET/MRI
Arm/Group Description	[18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer [18F] Fluciclovine PET/MRI: [18F] fluciclovine PET/MRI [18F] fluciclovine: [18F] fluciclovine
All Cause Mortality
	[18F] Fluciclovine PET/MRI
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Serious Adverse Events
	[18F] Fluciclovine PET/MRI
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	[18F] Fluciclovine PET/MRI
	Affected / at Risk (%)	# Events
Total	0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.