Prostate CancerPhase 2NCT02830880

FACBC Prostate Therapy Response

A Phase 2 study testing FACBC PET-CT and MRI, CT, or Bone Scan in people with Prostate Cancer, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: FACBC PET-CT and MRI, CT, or Bone Scan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Jul 2016to 30 Sep 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)
Ability to lie still for PET scanning
Ability to provide written informed consent

Who cannot join

Age less than 18 years
Inability to lie still for PET scanning
Inability provide written informed consent
Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Hospital
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging

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.

Read the detailed description

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.

Conditions: Prostate Cancer
Being tested: FACBC PET-CT, MRI, CT, or Bone Scan
Keywords: Imaging, Nuclear medicine, Oncology, Radiology, Urogenital disorders
Medical subject headings: Prostatic Neoplasms, Neoplasms, Urogenital Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FACBC PET-CTDrug
Also called Fluciclovine
Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.
MRI, CT, or Bone ScanOther
Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.

Study groups in NCT02830880
Study group	Role	What they receive
FACBC	Experimental	Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement will undergo an FACBC PET-CT scan. Receives: Drug: FACBC PET-CT; Other: MRI, CT, or Bone Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change Assessed by FACBC PET Scan
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.
Measured: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Prostate Specific Antigen Level
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.
Measured: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Number of Participants Responding to Treatment Assessed by MRI
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.
Measured: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
Number of Participants Responding to Treatment Assessed by CT Scan
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.
Measured: After Cycle 6 (Week 17)
Number of Participants With a Clinical Response Assessed by Bone Scan
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.
Measured: Baseline, After Cycle 6 (Week 17)

Secondary outcomes (1)

Number of Deaths
The number of deaths that have occurred was assessed at the end of study.
Measured: End of Study (up to 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201630 Sep 2019

First posted13 Jul 2016 (estimated)
Study startJul 2016
Primary completion1 Dec 2018
Study completion30 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02830880
Sponsor's protocol ID: IRB00073616
Status last verified: Dec 2019
First submitted: 30 Jun 2016
Last updated: 7 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.
PubMed 24144687

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging
ClinicalTrials.gov ID: NCT02830880
Acronym / sponsor ID: IRB00073616
Conditions: Prostate Cancer
Keywords: Imaging, Nuclear medicine, Oncology, Radiology, Urogenital disorders
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Blue Earth Diagnostics, Nihon Medi-Physics Co., Ltd.
Study start: Jul 2016 (actual)
Primary completion: 1 Dec 2018 (actual)
Study completion: 30 Sep 2019 (actual)
First posted: 13 Jul 2016 (estimated)
Results: Posted 18 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FACBC	Experimental	Drug: FACBC PET-CT, Other: MRI, CT, or Bone ScanParticipants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement will undergo an FACBC PET-CT scan.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)
Ability to lie still for PET scanning
Ability to provide written informed consent

Key exclusion criteria (4 listed)

Age less than 18 years
Inability to lie still for PET scanning
Inability provide written informed consent
Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FACBC PET-CTAlso: FluciclovineAnti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.	Drug	FACBC
MRI, CT, or Bone ScanConventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.	Other	FACBC

Primary outcome

Percent Change Assessed by FACBC PET Scan
Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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 Level
Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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.
Number of Participants Responding to Treatment Assessed by MRI
Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)
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.
Number of Participants Responding to Treatment Assessed by CT Scan
Time frame: After Cycle 6 (Week 17)
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.
Number of Participants With a Clinical Response Assessed by Bone Scan
Time frame: Baseline, After Cycle 6 (Week 17)
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.

1 secondary outcome

Number of Deaths
Time frame: End of Study (up to 1 year)

Results and safety

Results posted to the registry on 18 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FACBC PET-CT	7	4

Primary outcome: Percent Change Assessed by FACBC PET Scan

Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17). Mean (Standard Deviation). Unit: percent change of SUVmax

Measure	FACBC PET-CT n = 7
Percent change between Baseline and Cycle 1	3.2 (32.6)
Percent change between Baseline and Cycle 6	23.5 (21.4)

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

Primary outcome: Prostate Specific Antigen Level

Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17). Mean (Standard Deviation). Unit: nanograms per milliliter (ng/mL)

Measure	FACBC PET-CT n = 7
Baseline	249.8 (471.9)
After completing Cycle 1	245.3 (472.5)
After completing Cycle 6	39.9 (23.7)

Population analysed: This analysis includes participants completing the study visits.

Primary outcome: Number of Participants Responding to Treatment Assessed by MRI

Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

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

Primary outcome: Number of Participants Responding to Treatment Assessed by CT Scan

Time frame: After Cycle 6 (Week 17). Count of participants. Unit: Participants

Measure	FACBC PET-CT n = 4
Complete Response	0
Partial Response	0
Stable Disease	4
Progressive Disease	0

Population analysed: This analysis includes participants completing the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Information about adverse events that were potentially related to the radiotracer used for FACBC PET-CT scan was collected from the time of giving consent to participate in the study through the post-cycle 6 visit, approximately 17 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FACBC PET-CT	0 of 7 (0%)	0 of 7 (0%)	3 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24144687Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.
Individual participant dataSharing planned: No

Related trials for Prostate Cancer

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Schuster, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FACBC PET-CT and MRI, CT, or Bone Scan in people with Prostate Cancer, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change Assessed by FACBC PET Scan (time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02830880, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.