Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Urogenital Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement will undergo an FACBC PET-CT scan.

Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.

FACBC PET-CT

Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.

MRI, CT, or Bone Scan

David Schuster, MD

The purpose of this study is to assess if using anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment. Investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. Investigators aim to enroll thirty participants in this study.

The goal of the investigation is to examine therapeutic monitoring of chemotherapy in castrate resistant prostate carcinoma with anti-3-\[18F\]FACBC in prostate carcinoma to determine if anti-3-\[18F\]FACBC amino acid imaging can serve as an accurate and efficient imaging biomarker.

Investigators will perform a baseline anti-3-\[18F\]FACBC PET-CT of the whole body. All participants will also undergo conventional staging including 99mTc methylene diphosphonate (MDP) bone scanning and computed tomography scan (CT) or magnetic resonance imaging (MR) of the abdomen and pelvis which are standard of care at the enrolling institution. This study will not interfere with standard patient evaluation or delay therapy.

All 30 participants will receive chemotherapy every 3 weeks for 6 cycles. Participants will undergo a repeat anti-3-\[18F\]FACBC PET-CT after 1 and 6 cycles and also repeat conventional imaging including bone scanning CT or MR of the abdomen and pelvis after 6 cycles. At the end of the study, the study team will then record the response (or lack thereof) on anti-3-\[18F\]FACBC PET-CT and correlate that response with response per standard clinical criteria including bone scan uptake for skeletal lesions, CT or MR for soft tissue and skeletal lesions, prostate-specific antigen (PSA) progression or regression, and other clinical parameters such as declining performance status.

FACBC Prostate Therapy Response

Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging

Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.

Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer.

Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows:

* Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
* Complete Response Unknown (CRU)
* Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
* Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
* Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.

A CT will be used to assess response to treatment. Treatment response will be reported as follows:

* Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
* Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
* Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
* Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.

Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here.

The number of deaths that have occurred was assessed at the end of study.

Blue Earth Diagnostics

Nihon Medi-Physics Co., Ltd.

Emory University

Associate Professor

Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-\[18F\]FACBC radiotracer intravenously prior to PET scan.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Percent change between Baseline and Cycle 1

Percent change between Baseline and Cycle 6

This analysis includes participants completing the study visits used in each change from baseline determination.

Percent Change Assessed by FACBC PET Scan

Baseline

After completing Cycle 1

After completing Cycle 6

This analysis includes participants completing the study visits.

Prostate Specific Antigen Level

Data were not collected for this outcome measure as all participants had a CT scan rather than an MRI to assess response to treatment.

Number of Participants Responding to Treatment Assessed by MRI

This analysis includes participants completing the study.

Number of Participants Responding to Treatment Assessed by CT Scan

This analysis includes participants who completed the study.

Number of Participants With a Clinical Response Assessed by Bone Scan

Number of Deaths

Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC) radiotracer intravenously prior to positron emission tomography (PET) scan.

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Individuals who have been diagnosed with primary prostate carcinoma and do not have definitive findings of systemic metastasis with conventional imaging will have a whole body FACBC PET-CT scan.

Participants will fast for 4 hours to normalize their neutral amino acid levels. One hour prior to the scan, participants will drink up to 450ml of standard oral contrast. Participants will lie on the scanning bed while the bed moves through the PET/CT scanner for the CT portion of the exam. After completion of the CT scan, approximately 10 units of FACBC will be injected for the PET scan portion of the exam. The bed will move through the scanner again and the PET portion of the exam will take 30 minutes. The entire visit will take about two hours.

Standard of care procedures include conventional imaging (CT and/or MRI; bone scan and/or NaF PET per institutional standards) and radical prostatectomy with extended pelvic lymph node dissection.

FACBC PET-CT Imaging

Mehrdad Alemozaffar

David M Schuster, MD

This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-\[18F\]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.

Approximately 50-80% of patients who are considered high-risk after being treated with definitive radical prostatectomy experience recurrent disease, often because of undetected extra-prostatic metastatic disease prior to treatment. There is increasing evidence that performing radical prostatectomy in patients with high-risk disease or locally advanced disease is feasible and has potential benefits in terms of local control, overall survival, and quality of life. Thus, improved imaging approaches for early detection of occult metastatic prostate cancer at the time of presentation could inform a directed treatment approach that would significantly improve patient outcomes, including use of extended lymphadenectomy as well as postoperative radiation therapy planning.

Amino acid transport is up-regulated in prostate and other cancers. Anti-1-amino-3-\[18F\]fluorocyclobutyl-1-carboxylic acid (FACBC) is a synthetic amino acid analog positron emission tomography (PET) radiotracer that has demonstrated promising results in the staging and restaging of prostate carcinoma, with high positive predictive value (PPV) in the identification of extraprostatic malignancy. Most of the prior studies of FACBC were in post-primary treatment recurrence, and this proposed trial will be the first comprehensive study to evaluate FACBC PET in detecting occult metastatic disease at initial diagnosis in patients with negative or equivocal conventional imaging, with the objective of developing a more effective primary treatment plan.

The goal of this study is to determine if FACBC PET will detect significant occult metastatic disease in patients with high risk primary prostate carcinoma who have negative or equivocal conventional imaging such as CT and/or MRI and bone scan. Participants will have a single scan prior to surgery for this study. Participants will be followed, through medical record reviews, for 10 years but no additional procedures related to this study will be performed.

All participants will have the same intervention

Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease

Validation of FACBC as an Early Indicator of Sub-clinical Metastatic Disease Among High-risk Prostate Cancer Patients With Presumed Localized Disease

The performance of FACBC PET/CT for diagnosing metastatic cancer was determined by confirming the FACBC PET/CT findings to the histological analysis of the lymph nodes.

The diagnostic performance of FACBC PET/CT in the detection of extraprostatic disease is compared to the diagnostic performance of standard imaging, as confirmed with lymph node histology.

National Cancer Institute (NCI)

Professor

Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Type of Standard of Care Imaging

The baseline analysis population includes participants who completed the study.

David M. Schuster, MD

Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC PET-CT scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.

Cancer Detection Performance of FACBC PET/CT

Sensitivity

Specificity

Positive predictive value

Negative predictive value

Accuracy

Study participants also had conventional imaging (CT or MRI) as part of standard of care.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FACBC Prostate Therapy Response	NCT02830880	Prostate Cancer	FACBC PET-CT MRI, CT, or Bon...	18 Years -	Emory University
Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease	NCT03081884	Cancer	FACBC PET-CT Im...	18 Years -	Emory University
FACBC Prostate Therapy Response	NCT02830880	Prostate Cancer	FACBC PET-CT MRI, CT, or Bon...	18 Years -	Emory University

Spots Global Cancer Trial Database for urogenital disorders