[18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study
Phase: PHASE2
Conditions: Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer
Sponsor: University of Utah

 
Protocol Summary (ERICA) 
 
IRB_00113970 
Page 1 of 11 
 
IRB Approval 5/5/2022 
 
 
[18F]Fluciclovine Companion Imaging Study to Radium-
223 and Radiotherapy in Hormone-Naïve Men with 
Oligometastatic Prostate Cancer to Bone (RROPE) Study: 
IIT Fluciclovine Prostate
 
Protocol Summary 
 
 
IRB Approval 
Date of 
Current 
Version:
5/5/2022 
University of 
Utah IRB #:
IRB_00113970 
Sponsor:
HUNTSMAN CANCER INSTITUTE 
BLUE EARTH DIAGNOSTICS 
 
Principal 
Investigator:
John Hoffman 
Internal Staff 
and  Sub-
Investigators:
Site Name 
Staff Names 
University of Utah John Hoffman
Jonathan Tward
Kathryn Morton
Neeraj Agarwal
Kenneth Boucher
Lance Burrell
Zane Archibald
Jeffrey Yap
Matt Covington
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

 
Protocol Summary (ERICA) 
 
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Background and Introduction 
This is a companion imaging study to IRB #102312 (A Phase 2 Study of Radium-223 and 
Radiotherapy in Hormone-Naïve Men with Oligometastatic Prostate Cancer to Bone). This 
companion imaging study is designed to obtain pre-therapy, mid-therapy and post-therapy 
[18F]Fluciclovine –PET/CT imaging assessments of prostate cancer metastatic to bone and 
correlate the results with standard 99mTc-MDP bone scintigraphy and CT imaging. 
Prostate Cancer 
Prostate cancer is the most commonly diagnosed cancer in the United States and second 
leading cause of cancer death. At diagnosis, approximately 10% of men will have bone 
metastases identified on 99mTc-MDP bone scintigraphy (Klatte et al., 2006). These bone 
metastases can result in skeletal related events (SREs) causing substantial morbidity (Pelger et 
al., 2001). Men with five or fewer prostate cancer bone metastases noted on initial bone scan 
have a 94%, two year survival rate, and a significantly favorable overall survival when 
compared to those with more lesions (Soloway et al., 1988). The current standard of care for 
men with overt metastatic disease is immediate androgen deprivation therapy (ADT) (NCCN 
Guideline, 2017). Long term androgen deprivation therapy results in a significant decrement in 
quality of life (Bellmunt, 2013) and a host of unfavorable side effects including but not limited 
to loss of libido, lack of energy, difficulty concentrating, hot flashes, decreased bone density, 
decreased muscle mass, and increased risk of heart attack and stroke. Although ADT will 
delay the appearance of tumor related symptoms in metastatic patients, there are no data that it 
prolongs overall survival (NCCN Guideline, 2017). Developing novel strategies to control 
metastatic prostate cancer with side effect profiles superior to that of ADT or other approved 
systemic agents is highly desirable. External beam radiation treatment is effective at 
controlling both primary and metastatic prostate cancers, and Radium-223 has demonstrated a 
survival benefit in castrate-resistant prostate cancers. Both forms of therapy have been shown 
to palliate painful bony lesions. 
Imaging of Metastatic Prostate Cancer 
Currently, standard-of-care imaging for prostate cancer staging as recommended by the 
National Comprehensive Cancer Network guidelines includes 99mTc-MDP bone scintigraphy 
and pelvic imaging with CT or MRI (NCCN Prostate Cancer Guideline 2017). This includes 
initial staging and subsequent re-staging often in the setting of early biochemical relapse after 
prostatectomy. Unfortunately, these imaging studies are generally uninformative. The prostate 
cancer that is present at this time is often very small and even micro-metastatic and escapes 
detection on conventional imaging. As a result, clinicians must often decide for or against 
further local therapy (e.g., salvage external beam radiation therapy for biochemical recurrence 
after prostatectomy) as guided by nomogram-based probabilities rather than anatomic 
localization. The goal in imaging is to have a much more sensitive, specific and accurate 
imaging procedure for initial as well as follow-up imaging of prostate cancer. A more sensitive 
imaging modality that could offer anatomic localization within the clinical setting of early 
PSA relapse would better inform treatment decisions and improve the management of patients 
with apparent recurrence based on PSA levels. Prostate cancer functional imaging with PET is 
presently used on a limited basis. Widely available, PET or PET/CT with [18F] 
fluorodeoxyglucose (FDG) is not standard of care imaging as FDG uptake is usually low in 
prostate cancer prior to the development of castration-resistant disease. [18F] sodium fluoride 

 
Protocol Summary (ERICA) 
 
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PET is more sensitive than standard 99mTc-MDP bone scintigraphy, but both methods are 
non-specific and do not image cancer outside of the skeleton. Acetate- and choline-based PET 
tracers have been the subject of study but are not broadly approved and available. PET or 
PET/CT with the experimental L-leucine analog 18F-fluciclovine has demonstrated promise 
and is now approved for positron emission tomography (PET) imaging in men with suspected 
prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels 
following prior treatment (Axumin 2016). 
99mTc-MDP bone scintigraphy is the most commonly used technique to assess for metastatic 
bone disease. 99mTc-MDP is a nonspecific marker of osteoblastic activity accumulating in 
response to tumor as well as degenerative joint disease, benign fractures, and inflammation 
(Eustace et al., 1997; Hamaoka et al., 2004; Rybak et al., 2001). Another limitation of 
conventional 99mTc-MDP bone scintigraphy is that it only becomes positive at a fairly 
advanced stage of tumor infiltration, when osteoblastic reaction to metastatic cell deposit has 
occurred (Daldrup-Link et al., 2001). Sensitivities for tumor detection in bone as reported in 
the literature range between 62 and 89%. These levels are considered acceptable (Daldrup-
Link et al., 2001). A major limitation to 99mTc-MDP bone scintigraphy is the low specificity. 
This has led to a decreased diagnostic accuracy and this has led to concern about the procedure 
in the literature (Jacobson et al., 1998; Schirrmeister et al., 1999). Due to this relatively poor 
diagnostic accuracy, regions of increased uptake cannot be definitively characterized as 
negative or positive for malignancy. Phrases such as “equivocal,” “possible,” “suspicious,” 
“likely,” “highly suspicious,” “almost certain,” may be found in the bone scan report as it is 
not possible to be definitive that the osteoblastic activity is from malignancy or another 
etiology. Often an equivocal area of concern will be obtained to look for evidence of 
metastatic disease versus a benign etiology (Gosfield et al., 1993). Despite the use of the 
radiograph to improve specificity, the combination of 99mTc-MDP bone scintigraphy and 
plain film x-ray is imperfect. The diagnosis may remain equivocal after this workup. In clinical 
practice, a normal bone radiograph associated with an abnormal scan is highly suggestive of 
bone metastasis (McKillop et al., 1980). 
Computed tomography (CT) is an important tool in the management of almost all tumor types. 
It is the primary imaging modality used to stage patients as well as assess treatment response. 
It provides excellent resolution of cortical and trabecular bone. It is particularly helpful in 
assessing the ribs which have a high cortex to marrow ratio. It is possible to use dedicated 
bone algorithms on the acquired images to adjust the window and width and level. The 
resolution of the images is such that the skeleton can be viewed in multiple planes using multi-
planar reformatted images. These techniques maximize the conspicuity of bone lesions. This in 
turn results in higher sensitivity of CT compared to plain radiography in detecting both lytic 
and blastic metastases. An advantage of using CT to assess metastatic bone disease or response 
is that these assessments can be performed at the time of staging or restaging. CT has limited 
soft tissue resolution when compared to MRI, but despite this limitation, CT can demonstrate 
bone marrow metastases before bone destruction occurs which results in earlier diagnosis and 
can improve prognosis and prevent complications (Bäuerle et al., 2009). 
Clinical trials have demonstrated a role for CT in evaluating the sclerotic changes within a 
metastatic deposit. This change occurs in response to treatment of skeletal metastases with 
chemo/radiotherapy. The reactive sclerosis may be quantified by calculating the change in 

 
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Hounsfield units within metastatic deposits 
 
Computed tomography (CT) has the highest sensitivity and specificity for the detection of 
osteoblastic metastases with high Hounsfield units (HU), CT has limitations in the detection of 
osteolytic and bone marrow metastases (Lange et al., 2016, Evangelista et al., 2012). 
A list of references can be located in the full protocol. 
 
 
 
Purpose and Objectives 
This is a companion imaging study to IRB #102312 (A Phase 2 Study of Radium-223 and 
Radiotherapy in Hormone-Naïve Men with Oligometastatic Prostate Cancer to Bone). This 
companion imaging study is designed to obtain pre-therapy, mid-therapy and post-therapy 
[18F]Fluciclovine –PET/CT imaging assessments of prostate cancer metastatic to bone and 
correlate the results with standard 99mTc-MDP bone scintigraphy and CT imaging. 
Positron emission tomography (PET) is a molecular imaging modality that can probe various 
aspects of tumor function and biology using a variety of radiolabeled imaging agents 
(“tracers”). Oncologic PET imaging has seen a dramatic rise in clinical utilization over the past 
decade for cancer detection, staging, and evaluating residual or recurrent disease following 
therapy. These clinical scans use the FDA approved PET radiopharmaceutical [18F]fluoro-2-
deoxy-D-glucose (FDG), which accumulates in cells in proportion to GLUT transporter and 
hexokinase activity. FDG thus provides a measure of tissue glucose metabolism. On May 27, 
2016 [18F] anti-FACBC ([18F]Fluciclovine) with the brand name of Axumin was approved 
for detection of recurrent prostate cancer (Axumin 2016). ([18F]Fluciclovine is a synthetic L-
leucine analogue that is transported into cells but is not incorporated into proteins. Prostate 
cancer has upregulated amino acid utilization and thus increased [18F]Fluciclovine uptake. 
[18F]Fluciclovine provides a measure of tumor growth related to amino acid transport and 
utilization (Shoup and Goodman, 1999, Akhurst et al., 2006, Meirelles et al., 2006, Oka et al., 
2007, Yu 2009, Yu 2010, Oka et al., 2012). 
The patients will be hormone naïve and have 5 or fewer bone lesions and have no visceral 
metastatic disease. Treatment will include systemic Radium-223(6 possible treatments over 
approximately 6 months) and hypofractionated radiotherapy to oligometastatic sites. Certain 
patients may have progressive disease as determined on the primary protocol and will not 
receive additional Radium-223 treatments but will remain on the trial (IRB #102312).  
 
These preliminary and exploratory data will provide information regarding visual and semi-
quantitative [18F]Fluciclovine uptake and correlate these variables with changes in uptake on 
standard 99mTc-MDP bone scintigraphy and CT imaging. This unique situation will allow us 
to obtain an initial experience on the performance and correlation of [18F]Fluciclovine bone 
uptake in various metastatic subtypes (lytic, blastic, marrow, mixed) compared to standard 
imaging tests. 

 
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The hypothesis of this exploratory clinical trial in patients with prostate cancer metastatic to 
bone is that [18F]Fluciclovine–PET/CT uptake will correlate with the type of bone metastasis 
present (blastic, lytic, marrow, mixed) as has been seen in pre-clinical animal models. It is 
expected that lytic and marrow foci will exhibit the greatest [18F]Fluciclovine–PET/CT 
uptake. 
The primary exploratory objectives of the study are: 
• Abnormal [18F]Fluciclovine uptake on visual assessment will differ by the type of metastatic 
lesion present (blastic, lytic, marrow, mixed). 
• SUVmax and SUVmean on [18F]Fluciclovine-PET/CT imaging will differ by the type of 
metastatic lesion present (blastic, lytic, marrow, mixed). 
Secondary Exploratory Objectives are outlined below 
• Determine if a 25% or greater reduction in aveSUVmax or aveSUVmean on 
[18F]Fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive 
of increased time to biochemical failure. 
• Determine the correlation between the number of lesions, their visual uptake, and semi-
quantitative uptake on 99mTc-MDP bone scintigraphy and [18F]Fluciclovine- PET/CT at 
baseline 
• Determine the correlation between the number of lesions, their visual uptake, and semi-
quantitative uptake on 99mTc-MDP bone scintigraphy and [18F]Fluciclovine- PET/CT after 3 
and 6 cycles of treatment. 
 
 
 
Study Population 
Age of Participants: 18+ 
 
Sample Size: 
At Utah: 
15  
All Centers: 
18 
 
Inclusion Criteria: 
- Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in 
Hormone-Naïve Men with Oligometastatic Prostate Cancer to Bone). 
- Patients must document their willingness to be followed for up to 24 months after 
recruitment by signing informed consent documenting their agreement to allow access to the 
data obtained on IRB #102312 and information and data entered into a research database. 
- All patients, or their legal guardians, must sign a written informed consent and HIPAA 
authorization in accordance with institutional guidelines. 
 
 
Exclusion Criteria: 
- Patients with known allergic or hypersensitivity reactions to previously administered 
radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune 
diseases may be enrolled at the Investigator’s discretion.

 
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- Patients who require monitored anesthesia for PET scanning. 
- Patients who are too claustrophobic to undergo PET scanning. 
 
 
Design  
Prospective Biomedical Intervention or Experiment 
Open Label Trial 
 
 
 
 
Study Procedures 
Recruitment/Participant Identification Process: 
Patients must be enrolled on the parent study, 102312, so all patients will be recruited from 
that pool of patients. Once a new patient enrolls, the team for this study will be notified. 
Patients will not be approached with the approved consent form until the physician has first 
discussed the trial and assessed their interest. 
Information regarding this study will be posted on the Huntsman Cancer Institute web site 
(www.huntsmancancer.org), which could be another source of recruitment, as well as the 
Cancer Learning Center at the Huntsman Cancer Hospital. The HCI web site posting is 
automatically generated at IRB approval and utilizes the Objectives & Eligibility criteria from 
the ERICA application via the OnCore interface. 
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
Private room at a hospital or clinic within the University of Utah’s covered entity 
 
Description of the consent process(es), including the timing of consent:  
The consent form is given to the patient after initially discussing the trial with the treating 
physician. The patient is encouraged to take the consent home. The patient is allowed as much 
time as needed to consider fully if they want to participate in the study. The patient is 
encouraged to ask questions and to take the consent form home to discuss with family 
members or other physicians. There is no time limit on their decision, unless it impacts an 
immediate treatment decision. The consent process begins when the treating physician initially 
discusses the clinical trial with the potential participant. The consent form document is given 
to the patient for review. The participant is encouraged to take home the consent form for 
review and given contact information to contact the investigator and study team for any 
questions. After the patient has indicated their desire to participate, all elements of the 
document are reviewed and discussed. When all of the participants’ questions have been 
answered, his or her signature will be obtained, either in person or remotely. Due to the large 
geographic area that the University of Utah’s Covered Entity serves, travel to the clinic may 
be difficult for signing a document. We will allow participants to sign the document at a 
remote location and send to our site (via email, fax or mail) to initiate the screening process. 

 
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Patients who sign from a remote location will return their original ICF to the study team. If the 
original is unavailable, the patients will be asked to and sign another original in the presence 
of the study team.  
 
Procedures: 
As described in the consent form: 
Your participation for this study will consist of a screening visit (today), and up to three 
additional imaging sessions: 1) prior to any tumor-directed radiation therapy; 2) between 
months 3 and 4 of treatment or follow up; and 3) at approximately 6-7 months.  
Screening Visit 
Before the study starts, you will be asked to sign this informed consent form, and a member of 
the Study Staff will ask you about your general health history, treatments you have had for 
your prostate cancer, if you take any over-the-counter or prescription medicines, vitamins, or 
herbs, and if you have any drug allergies.  
The Study Staff will also record information from your medical records including previous 
blood test results, procedures, treatments, and plans for your prostate cancer treatment. 
If you agree to participate in the study and you qualify for the study, then you will be 
scheduled for your first scan before you receive any treatment with Radium 223.  The Study 
Staff will tell you when and where the PET/CT scan will be performed.  
Day of Imaging Session 1: Baseline 
Before the dosing of [18F]Fluciclovine and the PET/CT scan, a member of the Study Staff will 
ask you questions about any changes to your general health and medications since your 
screening visit.  
The following tests will be performed before dosing: 
 Measurement of your height and weight 
 Assessment of vital signs (blood pressure, heart rate, and temperature) 
PET/CT Scan [18F]Fluciclovine 
The Study Staff will place an IV catheter (long, thin tube) into a vein in your arm.  You will 
receive the [18F]Fluciclovine injection through the catheter in your arm immediately before 
the scan. During the scan, you will lie on your back on the scanning bed. The bed will move 
slowly through the PET/CT scanner. The CT portion of the scan usually takes about 1 minute, 
and sends X-rays through your body that are measured by the CT camera. The PET portion of 
the scan begins immediately after the CT scan and will last about 60 minutes. 
You should not exercise the day before the scan and until the scan is finished. Do not eat or 
drink for at least 8 hours before the scan; sips of water to take medication are permitted. 

 
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This entire visit should require approximately 2 to 3 hours of your time. 
Immediately Following Each Scan 
Immediately following the scan, a member of the study staff will obtain your vital signs, 
including your blood pressure, heart rate, and temperature. 
Day after Each Scan (or up to 3 days after scan) 
You will be contacted by a member of the Study Staff to discuss whether you have had any 
side effects within the 24 hours after you received the [18F]Fluciclovine. 
Day of Imaging Sessions 2 and 3: During Treatment and After Treatment with Radium 
223 
Similarly, prior to imaging sessions 2 and 3, a member of the Study Staff will ask you 
questions about any changes to your general health and medications since your screening 
visit.  
The following tests will be performed before dosing: 
 Measurement of your height and weight 
 Assessment of vital signs (blood pressure, heart rate, and temperature) 
PET/CT Scan [18F]Fluciclovine 
The process of placing an IV catheter, receiving the [18F]Fluciclovine injection, and the 
approximate 60 minute scan will remain the same as described in the baseline imaging.  You 
should not exercise the day before the scan and until the scan is finished.  Do not eat or drink 
for at least 8 hours before the scan; sips of water to take medications are permitted. 
This entire visit should require approximately 2 to 3 hours of your time. 
Immediately Following Each Scan 
Immediately following each scan, a member of the study staff will obtain your vital signs, 
including your blood pressure, heart rate, and temperature. 
Day after Each Scan (or up to 3 days after scan) 
You will be contacted by a member of the Study Staff to discuss whether you have had any 
side effects within the 24 hours after you received the [18F]Fluciclovine. 
Follow-up 
You will be followed up for 24 months after you sign the consent form. This will be done by 
reviewing your medical records.   

 
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Procedures performed for research purposes only:  
 
 
Statistical Methods, Data Analysis and Interpretation 
Data Analysis 
Qualitative and Visual Assessment. The images for the standard 99mTc-MDP bone 
scintigraphy and the [18F]Fluciclovine-PET/CT will be visually assessed for any artifacts. The 
images will then be independently scored as described earlier for each imaging modality based 
on the level of uptake and confidence of tumor presence. The concordance of the agreement 
will be assessed and compared with the CT determination of metastasis type (lytic, blastic, 
mixed). Data will then be assessed and tabulated on a lesion by lesion basis for all of the 
imaging modalities over time as to the presence and the confidence of metastatic prostate 
cancer. Bland-Altman plots will be prepared. 
Semi- and Fully-Quantitative Assessments. 
The primary analysis of SUVmax and SUVmean will be t-tests comparing the osteoblastic and 
osteolytic lesions. An additional analysis of the primary objective will be one way ANOVA 
with Tukey’s post hoc analysis comparing all four lesion types (osteoblastic, osteolytic, 
marrow and mixed).  As a secondary sensitivity analysis mixed effects models with a fixed 
effect for lesion type and a random patient effect will also be fit.  
Spearman correlation of lesion uptake on 99mTc-MDP bone scintigraphy and 
[18F]Fluciclovine- PET/CT at baseline and after 3 cycles of Radium 223 will be calculated. 
The number of lesions identified by 99mTc-MDP bone scintigraphy alone, [18F]Fluciclovine- 
PET/CT alone, and both  99mTc-MDP bone scintigraphy and [18F]Fluciclovine- PET/CT will 
be tabulated. 
Spearman correlation of lesion uptake on 99mTc-MDP bone scintigraphy and 
[18F]Fluciclovine- PET/CT at baseline and after 6 cycles will be calculated (6-7 months for 
those individuals who progressed). The number of lesions identified by 99mTc-MDP bone 
scintigraphy alone, [18F]Fluciclovine- PET/CT alone, and both  99mTc-MDP bone scintigraphy 
and [18F]Fluciclovine- PET/CT will be tabulated. 
Time to biochemical failure will be analyzed using standard survival analysis methods. Two 
binary variables will be constructed, by dividing the cohort into those that did and did not 
achieve a 25% or greater reduction in aveSUVmax or aveSUVmean on [18F]Fluciclovine-
PET/CT imaging after completion of all radiation therapy. Here aveSUVmax and aveSUVmean 
are defined as the average SUVmax and the average SUVmean across all identified 
lesions. Kaplan-Meier methods will be used for plotting and log rank tests will be used to 

 
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determine whether either of these binary variable is predictive of increased time to 
biochemical failure.   
Justification of Sample Size 
(Sample size calculations were prepared by Kenneth Boucher, Ph.D. of the HCI Biostatistics 
Resource) 
This is a companion study to IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy 
in Hormone-Naïve Men with Oligometastatic Prostate Cancer to Bone). The primary outcome 
of IRB #102312 is progression require ADT therapy. The planned accrual time is 12-24 
months with an additional 24 months of follow up. We provide sample size justifications for 
the primary objective.   
We focus on separate comparisons of the difference in SUVmax and SUVmean in osteolytic vs 
osteoblastic lesions. Both SUVmax and SUVmean are expected to be appreciably higher in 
osteolytic lesions.  The data available for assessment of power is sparse.  Oka reported tumor 
to background (T/BG) ratios of approximately 3 ± 1.0 and 4.5 ± 1.0 (mean  ± SD) for  14C-
fluciclovine uptake in osteoblastic and osteolytic lesions respectively in bone metastasis 
models in mice (Oka et al. 2017). A recent human study by Janssen provides some information 
that can be used in the current study to determine the sample size (Janssen et al 2017). The 
study assessed [68Ga]PSMA-HBED-CC uptake in osteolytic, osteoblastic, and bone marrow 
metastases in prostate cancer patients. It is expected that the [68Ga]PSMA-HBED-CC and 
[18F]Fluciclovine will behave similarly for the detection of bone metastases depending on the 
type (blastic, lytic, marrow, mixed).  As reported in table 3 of that manuscript, a median 
SUVmax for [68Ga]PSMA-HBED-CC imaging of 10.6 ± 7.1  and 24.0 ± 19.3 in osteoblastic 
and osteolytic bone metastases in prostate cancer patients with at least one bone metastasis 
(Janssen et al 2017, The number of osteolytic and osteoblastic lesions in the study were 21/154 
(13.6%) and 80/154 (51.9%) respectively, and there were approximately 5 lesions per subject 
(154 lesions in 30 patients). 
Guided by the data in Janssen (Janssen et al., 2017) we assume: 
1. 5 lesions per subject. As in Janssen (Janssen et al., 2017) uptake of lesions in the same 
patient is assumed to be independent. 
2. A standard deviation of 14.5 for mean SUVmax or SUVmean. 
3. The proportion of osteoblastic and osteolytic lesions will be 50% and 13% 
respectively. 
4. The use of separate two sample t- tests at the one sided 0.05 significance level for 
comparison of SUVmax and SUVmean between osteoblastic and osteolytic lesions. 
With these assumptions a sample size of 18 evaluable subjects will provide 80% power to 
detect a difference of 14.7 in mean SUVmax or SUVmean between osteolytic and osteoblastic 
lesions. 

 
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