Prostate CancerPhase 1/2NCT00924313
Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer
A Phase 1/2 study testing (C-11 Acetate) in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) 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?
- (C-11 Acetate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2008to 19 Apr 2011
- Phase
- Phase 1/2
- 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
- Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
- Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained. Knowledge of the location of each specimen is required for inclusion.
- Participant must be 18 years or older.
- Serum creatinine within 1 week prior to magnetic resonance (MR) imaging less than or equal to 1.8mg/dl AND epidermal growth factor receptor (eGFR) must be greater than 30 ml/min/1.73 m^2
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1.
- Ability to provide informed consent. All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Who cannot join
- Known allergy to gadolinium or acetate.
- Participants for whom participating would significantly delay the scheduled standard of care therapy.
- Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
- Participants with severe claustrophobia.
- Patients with contraindications to magnetic resonance imaging (MRI)
- Patients weighing greater than 136 kg (weight limit for scanner table).
Show all 13Show fewer
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
- Patients with contraindication to endorectal coil placement
- Severe hemorrhoids.
- Surgically absent rectum.
- Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol procedures.
- Patients who have previously received radiation therapy to the pelvis.
- Patients who have received androgen deprivation therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of 11C-Acetate Positron Emission Tomography (PET) and 3 Telsa Magnetic Resonance Imaging (MRI) in Men With Prostate Cancer Undergoing Prostatectomy
Background:
- Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) scans.
- An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor cells and may help find prostate cancers more accurately than other imaging methods.
Read more
Objectives:
- To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate.
Eligibility:
- Patients 18 years of age and older who are undergoing surgery for localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
Design:
- Patients have a positron emission tomography (PET scan). For this test, an intravenous (IV) line is placed in the patient's arm and the patient lies on a table inside the donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and images of the lower pelvis and abdomen are obtained over 30 minutes.
- Patients have an endorectal coil MRI scan. For this test, a tube is placed in the rectum, just behind the prostate, to increase the amount of signal received by the magnetic resonance (MR) unit. Other coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on the scanning table for about 75 to 90 minutes while images are obtained. During the scan, a contrast agent called gadolinium is injected through an intravenous (IV) line to brighten the images.
Read the detailed description
Background:
- Accurate localization of prostate cancer (PC) is important in developing targeted minimally invasive therapies. While T2 weighted imaging, dynamic contrast enhanced (DCE) imaging, diffusion weighted imaging (DWI), and magnetic resonance (MR) spectroscopy imaging performed at 3T is a useful technique for localizing prostate cancer, it has limitations both in sensitivity and specificity.
- Positron emission tomography (PET) radiopharmaceuticals are more sensitive than magnetic resonance imaging (MRI) for the detection of cancers; however, the resolution of PET is inferior to MRI. Therefore, a combined PET/MR approach might be desirable.
- We propose to evaluate the utility of a PET radiopharmaceutical, (11C) acetate ((11C)AC) for the detection of PC within the prostate and compare its distribution with T2 weighted imaging, dynamic contrast enhanced (DCE) imaging, diffusion weighted imaging (DWI), and MR spectroscopy imaging preformed at 3T.
- Unlike fludeoxyglucose F18(18F)FDG, a routinely used PET radiopharmaceutical which is excreted by the urinary system and accumulates in the bladder, limiting its utility in pelvic imaging, (11C)AC has low physiologic distribution in the pelvis. Several studies involving small numbers of patients have demonstrated that (11C)AC PET imaging can localize in pelvic nodes involved with prostate cancer (PC).
- Dynamic (11C)AC PET/CT examination will be performed in patients with biopsy proven prostate cancer (estimated enrollment 40) who will also undergo prostate/pelvic 3T endorectal coil MR/magnetic resonance spectroscopic imaging (MRSI) followed by surgical resection (+/- pelvic lymphadenectomy).
- Histological comparison with the PET/CT and MRI results will be conducted. This study of (11C)AC in PC will permit the direct comparison of MR/MRSI and (11C)AC PET/CT in the detection of prostate cancer within the prostate.
Objectives:
Primary Objective:
- To compare the biodistribution of (11C) acetate ((11C)AC) PET/CT imaging in tumor and non-tumorous regions of the prostate in patients with known prostate cancer.
Secondary Objective:
- To examine the diagnostic accuracy of the standardized uptake value (SUV) of (11C)AC obtained using PET/CT imaging for detecting region (sextant)-specific malignancy using receiver operating curves (ROC).
- To examine whether pelvic biodistribution of (11C)AC PET/CT imaging predicts sextant-specific malignancy better than T2 weighted imaging, dynamic contrast enhanced (DCE) imaging, diffusion weighted imaging (DWI), and MR spectroscopy (MRS) imaging performed at 3T.
- To evaluate for potential physiological effects of (11C)AC
- To correlate the intensity of (11C)AC uptake with histopathologic Gleason Grade
- Tabulate the incidence of extraprostatic lesions accumulating(11C)AC PET/CT detection which are suspicious for extraprostatic disease by comparing suspicious lesions on (11C)AC PET/CT with standard of care diagnostic imaging modalities, additional biopsy results, or clinical follow-up performed at the discretion of the referring physician.
Eligibility:
- Participants must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
- Recent (within 12 months of study entry) biopsy indicating the presence of adenocarcinoma of the prostate gland
- Participant must be 18 years or older
- Serum creatinine within 1 week prior to MR imaging less than or equal to 1.8mg/dl AND epidermal growth factor receptor (eGFR) must be greater than 30 ml/min/1.73m^2
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1
- Participants may not have received androgen deprivation therapy or pelvic radiation therapy
Design:
- Participants with prostate cancer scheduled for prostatectomy at the NIH Clinical Center will undergo 30-minute dynamic (11C)AC PET/CT imaging, and endorectal coil/pelvic T2 weighted, DCE, DWI, and MRS imaging performed at 3T.
- We will accrue 40 participants to this study.
- Conditions
- Prostate Cancer
- Being tested
- (C-11 Acetate)
- Keywords
- Prostate Cancer, MRI, C-11 Acetate, PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(C-11 Acetate)Drug
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
| Study group | Role | What they receive |
|---|---|---|
| 11C-acetate for Prostate Cancer Patients | Experimental | 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection Receives: Drug: (C-11 Acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate
Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.
Measured: 2 years
Secondary outcomes (8)
Count of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Measured: 2 years
Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm
The diagnostic accuracy of 11C-Acetate PET/CT imaging in prostate cancer was compared with multi-parametric magnetic resonance imaging (MP-MRI) using sector based analysis, generating receiver-operating-characteristic (ROC) curves (plots of 1-specificity versus sensitivity) for both modalities.
Measured: 2 years
Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging
Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV).
Measured: 2 years
Count of Participants With Physiological Effects of [11C]AC
Buildup of positron emission tomography (PET) radiopharmaceuticals excreted by the urinary system can accumulate in the bladder and limit pelvic imaging. This effect contributes to low physiologic distribution in the pelvis.
Measured: 2 years
Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection
Suspicious lesions noted on biopsy were compared with standard care imaging diagnostic modalities, additional biopsies, and/or clinical follow up performed at the discretion of the referring physician.
Measured: 2 years
Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score
Intensity [11C]AC uptake with histopathologic Gleason grade were done with a Spearman rank correlation following prostatectomy. Two biopsies were performed and graded according to tumor pattern. The two grades were added together for a final Gleason score. Gleason score equal to or less than 3+4 is considered low risk. Gleason score equal to or greater than 4+3 is considered high-risk.
Measured: 2 years
Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI.
PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity.
Measured: 2 years
11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation
Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start10 Sep 2008
- Primary completion19 Apr 2011
- Study completion19 Apr 2011
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 National Cancer Institute (NCI)The 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Peter Choyke, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Peter L Choyke, M.D., Principal investigator, National Cancer Institute, National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924313
- Sponsor's protocol ID
- 080226
- Other IDs
- 08-C-0226
- Status last verified
- Jun 2017
- First submitted
- 17 Jun 2009
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oyama N, Miller TR, Dehdashti F, Siegel BA, Fischer KC, Michalski JM, Kibel AS, Andriole GL, Picus J, Welch MJ. 11C-acetate PET imaging of prostate cancer: detection of recurrent disease at PSA relapse. J Nucl Med. 2003 Apr;44(4):549-55.
PubMed 12679398Jung 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 15564406Mena E, Turkbey B, Mani H, Adler S, Valera VA, Bernardo M, Shah V, Pohida T, McKinney Y, Kwarteng G, Daar D, Lindenberg ML, Eclarinal P, Wade R, Linehan WM, Merino MJ, Pinto PA, Choyke PL, Kurdziel KA. 11C-Acetate PET/CT in localized prostate cancer: a study with MRI and histopathologic correlation. J Nucl Med. 2012 Apr;53(4):538-45. doi: 10.2967/jnumed.111.096032. Epub 2012 Feb 17.
PubMed 22343504
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 11C-Acetate Positron Emission Tomography (PET) and 3 Telsa Magnetic Resonance Imaging (MRI) in Men With Prostate Cancer Undergoing Prostatectomy
- ClinicalTrials.gov ID
- NCT00924313
- Acronym / sponsor ID
- 080226
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, MRI, C-11 Acetate, PET
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 10 Sep 2008 (actual)
- Primary completion
- 19 Apr 2011 (actual)
- Study completion
- 19 Apr 2011 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Posted 17 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) scans.
- An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor cells and may help find prostate cancers more accurately than other imaging methods.
Objectives:
- To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate.
Eligibility:
- Patients 18 years of age and older who are undergoing surgery for localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
Design:
- Patients have a positron emission tomography (PET scan). For this test, an intravenous (IV) line is placed in the patient's arm and the patient lies on a table inside the donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and images of the lower pelvis and abdomen are obtained over 30 minutes.
- Patients have an endorectal coil MRI scan. For this test, a tube is placed in the rectum, just behind the prostate, to increase the amount of signal received by the magnetic resonance (MR) unit. Other coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on the scanning table for about 75 to 90 minutes while images are obtained. During the scan, a contrast agent called gadolinium is injected through an intravenous (IV) line to brighten the images.
Detailed description
Background:
- Accurate localization of prostate cancer (PC) is important in developing targeted minimally invasive therapies. While T2 weighted imaging, dynamic contrast enhanced (DCE) imaging, diffusion weighted imaging (DWI), and magnetic resonance (MR) spectroscopy imaging performed at 3T is a useful technique for localizing prostate cancer, it has limitations both in sensitivity and specificity.
- Positron emission tomography (PET) radiopharmaceuticals are more sensitive than magnetic resonance imaging (MRI) for the detection of cancers; however, the resolution of PET is inferior to MRI. Therefore, a combined PET/MR approach might be desirable.
- We propose to evaluate the utility of a PET radiopharmaceutical, (11C) acetate ((11C)AC) for the detection of PC within the prostate and compare its distribution with T2 weighted imaging, dynamic contrast enhanced (DCE) imaging, diffusion weighted imaging (DWI), and MR spectroscopy imaging preformed at 3T.
- Unlike fludeoxyglucose F18(18F)FDG, a routinely used PET radiopharmaceutical which is excreted by the urinary system and accumulates in the bladder, limiting its utility in pelvic imaging, (11C)AC has low physiologic distribution in the pelvis. Several studies involving small numbers of patients have demonstrated that (11C)AC PET imaging can localize in pelvic nodes involved with prostate cancer (PC).
- Dynamic (11C)AC PET/CT examination will be performed in patients with biopsy proven prostate cancer (estimated enrollment 40) who will also undergo prostate/pelvic 3T endorectal coil MR/magnetic resonance spectroscopic imaging (MRSI) followed by surgical resection (+/- pelvic lymphadenectomy).
- Histological comparison with the PET/CT and MRI results will be conducted. This study of (11C)AC in PC will permit the direct comparison of MR/MRSI and (11C)AC PET/CT in the detection of prostate cancer within the prostate.
Objectives:
Primary Objective:
- To compare the biodistribution of (11C) acetate ((11C)AC) PET/CT imaging in tumor and non-tumorous regions of the prostate in patients with known prostate cancer.
Secondary Objective:
- To examine the diagnostic accuracy of the standardized uptake value (SUV) of (11C)AC obtained using PET/CT imaging for detecting region (sextant)-specific malignancy using receiver operating curves (ROC).
- To examine whether pelvic biodistribution of (11C)AC PET/CT imaging predicts sextant-specific malignancy better than T2 weighted imaging, dynamic contrast enhanced (DCE) imaging, diffusion weighted imaging (DWI), and MR spectroscopy (MRS) imaging performed at 3T.
- To evaluate for potential physiological effects of (11C)AC
- To correlate the intensity of (11C)AC uptake with histopathologic Gleason Grade
- Tabulate the incidence of extraprostatic lesions accumulating(11C)AC PET/CT detection which are suspicious for extraprostatic disease by comparing suspicious lesions on (11C)AC PET/CT with standard of care diagnostic imaging modalities, additional biopsy results, or clinical follow-up performed at the discretion of the referring physician.
Eligibility:
- Participants must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
- Recent (within 12 months of study entry) biopsy indicating the presence of adenocarcinoma of the prostate gland
- Participant must be 18 years or older
- Serum creatinine within 1 week prior to MR imaging less than or equal to 1.8mg/dl AND epidermal growth factor receptor (eGFR) must be greater than 30 ml/min/1.73m^2
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1
- Participants may not have received androgen deprivation therapy or pelvic radiation therapy
Design:
- Participants with prostate cancer scheduled for prostatectomy at the NIH Clinical Center will undergo 30-minute dynamic (11C)AC PET/CT imaging, and endorectal coil/pelvic T2 weighted, DCE, DWI, and MRS imaging performed at 3T.
- We will accrue 40 participants to this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 11C-acetate for Prostate Cancer Patients | Experimental | Drug: (C-11 Acetate)11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
- Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained. Knowledge of the location of each specimen is required for inclusion.
- Participant must be 18 years or older.
- Serum creatinine within 1 week prior to magnetic resonance (MR) imaging less than or equal to 1.8mg/dl AND epidermal growth factor receptor (eGFR) must be greater than 30 ml/min/1.73 m^2
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1.
Key exclusion criteria (13 listed)
- Known allergy to gadolinium or acetate.
- Participants for whom participating would significantly delay the scheduled standard of care therapy.
- Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
- Participants with severe claustrophobia.
- Patients with contraindications to magnetic resonance imaging (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 |
|---|---|---|
| (C-11 Acetate)11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection | Drug | 11C-acetate for Prostate Cancer Patients |
Primary outcome
Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate
Time frame: 2 years
Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.
8 secondary outcomes
Count of Participants With Adverse Events
Time frame: 2 years
Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm
Time frame: 2 years
Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging
Time frame: 2 years
Count of Participants With Physiological Effects of [11C]AC
Time frame: 2 years
Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection
Time frame: 2 years
Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score
Time frame: 2 years
Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI.
Time frame: 2 years
11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12679398Oyama N, Miller TR, Dehdashti F, Siegel BA, Fischer KC, Michalski JM, Kibel AS, Andriole GL, Picus J, Welch MJ. 11C-acetate PET imaging of prostate cancer: detection of recurrent disease at PSA relapse. J Nucl Med. 2003 Apr;44(4):549-55.
- 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.
- Results publication: PubMed 22343504Mena E, Turkbey B, Mani H, Adler S, Valera VA, Bernardo M, Shah V, Pohida T, McKinney Y, Kwarteng G, Daar D, Lindenberg ML, Eclarinal P, Wade R, Linehan WM, Merino MJ, Pinto PA, Choyke PL, Kurdziel KA. 11C-Acetate PET/CT in localized prostate cancer: a study with MRI and histopathologic correlation. J Nucl Med. 2012 Apr;53(4):538-45. doi: 10.2967/jnumed.111.096032. Epub 2012 Feb 17.
- Individual participant dataSharing planned: No
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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.
Peter L Choyke, M.D. principal investigator
National Cancer Institute, National Institutes of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing (C-11 Acetate) in people with Prostate Cancer, run by National Cancer Institute (NCI) 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 6 inclusion and 13 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 11 Jul 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 17 Aug 2012). 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?
Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate (time frame: 2 years). 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 NCT00924313, 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 11 Jul 2017.