GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer

A Phase 2 study testing GE-148 (18F) in people with Prostate Cancer, run by GE Healthcare at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Background: GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers are interested in combining the drug with a small amount of radioactive material to allow prostate cancer lesions to appear more clearly on imaging scans. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: GE-148 (18F)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Mar 2012
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

Subject is male and is greater than or equal to 18 years old.
Subject must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.
Recent (within 12 months of study entry but not within 8-12 weeks before start of imaging study) prostate biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained.
Subjects must have a minimum of 1 positive-for-cancer biopsy core.
Serum creatinine within 2 weeks prior to MR imaging less than or equal to 1.8 mg/dl and eGFR must be greater than 30 ml/min/1.73m(2)
Chemistry parameters: AST and ALT 2 x of the upper limits of normal; total bilirubin, of less than or equal to 2 x the upper limits of normal or less than 3.0 mg/dl in patients with Gilbert's syndrome.

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Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.
The subject has a clinically acceptable medical history, physical examination and vital signs findings during the screening period (from within 21 days before administration of GE-148 (18F) Injection).

Who cannot join

Known allergy to gadolinium.
Subjects for whom participating would significantly delay the scheduled standard of care therapy.
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Subjects with severe claustrophobia unresponsive to oral anxiolytics.
Subjects with contraindications to MRI
Subjects weighing more than 136 kg (weight limit for scanner table).

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Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
Subjects with contraindication to endorectal coil placement
Severe hemorrhoids.
Surgically absent rectum.
Other medical conditions deemed by the principle investigator (or associates) or sponsor to make the subject ineligible for protocol procedures.
Subjects who have previously received radiation therapy to the pelvis.
Subjects who have received androgen-deprivation therapy.
The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 week after administration of GE-148 (18F) Injection.
Subjects with chronic renal failure (eGFR less than 30 ml/min/1.73m(2)).

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: GE148-002: A Phase 2, Open-label, Single-Center, Study to Assess GE-148 (18F) Injection Positron Emission Tomography(PET) Imaging to Detect Localized Prostate Cancer

Background:

GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers are interested in combining the drug with a small amount of radioactive material to allow prostate cancer lesions to appear more clearly on imaging scans. Researchers are also interested in determining whether the combination can help make cancer cells in pelvic lymph nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine individuals who are scheduled to have surgery on their prostate cancer.

Objectives:

To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer cells in pelvic lymph nodes using positron emission tomography and magnetic resonance imaging scanning.

Eligibility:

Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have prostate removal surgery.

Design:

Participants will be screened with a physical examination, medical history, blood tests, and imaging studies.
Participants will have magnetic resonance imaging (MRI) and positron emission tomography (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and PET scans may be performed on the same day or on different days, depending on the schedule set by the study researchers.
Tissue samples taken during prostate removal surgery, including prostate tissue and pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148 (18F).

Read the detailed description

Background:

Accurate imaging of prostate cancer is important for developing targeted minimally invasive therapies
GE-148 (18F) Injection is a drug product formulation known as [18F]FACBC which is a synthetic leucine amino acid analogue. Preliminary studies demonstrated efficacy in primary prostate cancer and metastatic/recurrent prostate cancers. We propose to evaluate GE-148 (18F) Injection as a PET radiopharmaceutical for the detection of prostate cancer.

Objectives: Primary Objective:

To differentiate the magnitude of uptake and retention of GE-148 (18F) Injection between malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue in subjects with prostate cancer.
To assess the safety of a single dose of GE-148 (18F) Injection in subjects with prostate cancer.

Secondary Objectives:

To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative assessment of AAT expression in malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue.
To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative assessment of Ki-67 expression in malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue.
To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection in malignant prostate tumors and their Gleason Score.
To assess the ability of GE-148 (18F) Injection to detect the number of discrete malignant prostate tumors confirmed by histopathology.
To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative measurement of AAT and Ki-67 expression in pelvic lymph nodes showing uptake of GE-148 (18F) Injection, where available.
To compare the ability of PET/CT imaging with GE-148 (18F) Injection to predict prostate malignancy and distinguish it from other pathologies (inflammation, hyperplasia, atrophy, hemorrhage) with that of T2W MRI, DCE MRI, MR DWI, and MRSI performed at 3T.

Eligibility:

Subject is 18 years old, ECOG 0-2, with documented prostate cancer (minimum 1 core).
Subject must be scheduled to undergo standard of care prostatectomy at NIH CC

Serum creatinine within 2 weeks prior to MRI less than or equal to1.8mg/dl, estimated GFR(eGFR) must be greater than 30 ml/min/1.73m2.

-Chemistry parameters: Aspartate aminotransferase (AST), Alanine transferase (ALT)2 x of the upper limits of normal; total bilirubin, of less than 2 x the upper limits of normal or less than 3.0 mg/dl in patients with Gilbert's syndrome.

Design:

Thirty subjects with localized prostate cancer scheduled for prostatectomy will undergo dynamic GE-148 (18F) Injection PET/CT imaging, and undergo a standard-of-care endorectal coil/pelvic multiparametric MRI . Results will be compared with pathology.

Conditions: Prostate Cancer
Being tested: GE-148 (18F)
Keywords: Prostate Cancer, MRI, PET, GE-148 (18F)
Medical subject headings: Prostatic Neoplasms

What participants receive

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

GE-148 (18F)Drug
Also called GE-148 (18F) Injection
All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.

Study groups in NCT01176513
Study group	Role	What they receive
GE 148-002	Experimental	Not described Receives: Drug: GE-148 (18F)

What is being measured

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

To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.
Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.
Measured: After GE-148 (18F) Injection administration.

Secondary outcomes (1)

To Compare the Ability of PET/CT Imaging With GE-148 (18F) Injection to Predict Prostate Malignancy and Distinguish it From Other Pathologies (Inflammation, Hyperplasia, Atrophy, Hemorrhage) With That of T2W MRI, DCE MRI, MR DWI, and MRSI Performed at 3T.
Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.
Measured: After GE-148 (18F) Injection administration

Timeline

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

Jul 2010Mar 2012

First posted6 Aug 2010 (estimated)
Study startJul 2010
Primary completionMar 2012
Study completionMar 2012

Why it stopped: Lack of Subject enrollment

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 (3)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 GE HealthcareThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01176513
Sponsor's protocol ID: GE-148-002
Other IDs: 10-C-0179
Status last verified: Jan 2014
First submitted: 5 Aug 2010
Last updated: 14 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672.
PubMed 15564406
Swindle P, Eastham JA, Ohori M, Kattan MW, Wheeler T, Maru N, Slawin K, Scardino PT. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol. 2005 Sep;174(3):903-7. doi: 10.1097/01.ju.0000169475.00949.78.
PubMed 16093984
el-Gabry EA, Halpern EJ, Strup SE, Gomella LG. Imaging prostate cancer: current and future applications. Oncology (Williston Park). 2001 Mar;15(3):325-36; discussion 339-42.
PubMed 11301831

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 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GE148-002: A Phase 2, Open-label, Single-Center, Study to Assess GE-148 (18F) Injection Positron Emission Tomography(PET) Imaging to Detect Localized Prostate Cancer
ClinicalTrials.gov ID: NCT01176513
Acronym / sponsor ID: GE-148-002
Conditions: Prostate Cancer
Keywords: Prostate Cancer, MRI, PET, GE-148 (18F)
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of Subject enrollment
Enrolment: 25 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: National Cancer Institute (NCI)
Study start: Jul 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 6 Aug 2010 (estimated)
Results: Posted 21 Nov 2013

Clinical summary

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

Background:

GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers are interested in combining the drug with a small amount of radioactive material to allow prostate cancer lesions to appear more clearly on imaging scans. Researchers are also interested in determining whether the combination can help make cancer cells in pelvic lymph nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine individuals who are scheduled to have surgery on their prostate cancer.

Objectives:

To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer cells in pelvic lymph nodes using positron emission tomography and magnetic resonance imaging scanning.

Eligibility:

Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have prostate removal surgery.

Design:

Participants will be screened with a physical examination, medical history, blood tests, and imaging studies.
Participants will have magnetic resonance imaging (MRI) and positron emission tomography (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and PET scans may be performed on the same day or on different days, depending on the schedule set by the study researchers.
Tissue samples taken during prostate removal surgery, including prostate tissue and pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148 (18F).

Detailed description

Background:

Accurate imaging of prostate cancer is important for developing targeted minimally invasive therapies
GE-148 (18F) Injection is a drug product formulation known as [18F]FACBC which is a synthetic leucine amino acid analogue. Preliminary studies demonstrated efficacy in primary prostate cancer and metastatic/recurrent prostate cancers. We propose to evaluate GE-148 (18F) Injection as a PET radiopharmaceutical for the detection of prostate cancer.

Objectives: Primary Objective:

To differentiate the magnitude of uptake and retention of GE-148 (18F) Injection between malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue in subjects with prostate cancer.
To assess the safety of a single dose of GE-148 (18F) Injection in subjects with prostate cancer.

Secondary Objectives:

To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative assessment of AAT expression in malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue.
To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative assessment of Ki-67 expression in malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate tissue.
To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection in malignant prostate tumors and their Gleason Score.
To assess the ability of GE-148 (18F) Injection to detect the number of discrete malignant prostate tumors confirmed by histopathology.
To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection with quantitative measurement of AAT and Ki-67 expression in pelvic lymph nodes showing uptake of GE-148 (18F) Injection, where available.
To compare the ability of PET/CT imaging with GE-148 (18F) Injection to predict prostate malignancy and distinguish it from other pathologies (inflammation, hyperplasia, atrophy, hemorrhage) with that of T2W MRI, DCE MRI, MR DWI, and MRSI performed at 3T.

Eligibility:

Subject is 18 years old, ECOG 0-2, with documented prostate cancer (minimum 1 core).
Subject must be scheduled to undergo standard of care prostatectomy at NIH CC

Serum creatinine within 2 weeks prior to MRI less than or equal to1.8mg/dl, estimated GFR(eGFR) must be greater than 30 ml/min/1.73m2.

Design:

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GE 148-002	Experimental	Drug: GE-148 (18F)

Who may qualify

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

Key inclusion criteria (9 listed)

Subject is male and is greater than or equal to 18 years old.
Subject must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.
Recent (within 12 months of study entry but not within 8-12 weeks before start of imaging study) prostate biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained.
Subjects must have a minimum of 1 positive-for-cancer biopsy core.
Serum creatinine within 2 weeks prior to MR imaging less than or equal to 1.8 mg/dl and eGFR must be greater than 30 ml/min/1.73m(2)

Key exclusion criteria (15 listed)

Known allergy to gadolinium.
Subjects for whom participating would significantly delay the scheduled standard of care therapy.
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Subjects with severe claustrophobia unresponsive to oral anxiolytics.
Subjects with contraindications to MRI

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
GE-148 (18F)Also: GE-148 (18F) InjectionAll subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.	Drug	GE 148-002

Primary outcome

To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.
Time frame: After GE-148 (18F) Injection administration.
Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.

1 secondary outcome

To Compare the Ability of PET/CT Imaging With GE-148 (18F) Injection to Predict Prostate Malignancy and Distinguish it From Other Pathologies (Inflammation, Hyperplasia, Atrophy, Hemorrhage) With That of T2W MRI, DCE MRI, MR DWI, and MRSI Performed at 3T.
Time frame: After GE-148 (18F) Injection administration

Results and safety

Results posted to the registry on 21 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GE 148-002	25	22

Primary outcome: To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.

Time frame: After GE-148 (18F) Injection administration.

Population analysed: Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GE 148-002	0 of 22 (0%)	2 of 22 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15564406Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672.
Background: PubMed 16093984Swindle P, Eastham JA, Ohori M, Kattan MW, Wheeler T, Maru N, Slawin K, Scardino PT. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol. 2005 Sep;174(3):903-7. doi: 10.1097/01.ju.0000169475.00949.78.
Background: PubMed 11301831el-Gabry EA, Halpern EJ, Strup SE, Gomella LG. Imaging prostate cancer: current and future applications. Oncology (Williston Park). 2001 Mar;15(3):325-36; discussion 339-42.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.

Related trials for Prostate Cancer

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
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RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

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.

Paul Gordon, PhD study director

GE Healthcare

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 GE-148 (18F) in people with Prostate Cancer, run by GE Healthcare 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 Feb 2014. 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 21 Nov 2013). 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?

To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging. (time frame: After GE-148 (18F) Injection administration.). 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 NCT01176513, which also lists 3 linked publications.

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 14 Feb 2014.