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CompletedNCT00924313Updated Jul 11, 2017Results posted

Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer

A Phase 1/2 interventional study of (C-11 Acetate) in Prostate Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Diagnostic

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Sep 2008, registered Jun 2009).
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.
  • 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.
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.
02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer
  • MRI
  • C-11 Acetate
  • PET
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 40 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

EXCLUSION CRITERIA:

  • 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).
  • 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    11C-acetate for Prostate Cancer Patients

    11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection

    Drug: (C-11 Acetate)

Interventions

  • Drug(C-11 Acetate)

    11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

  3. 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).

    Time frame: 2 years

  4. 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.

    Time frame: 2 years

  5. 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.

    Time frame: 2 years

  6. 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.

    Time frame: 2 years

  7. 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.

    Time frame: 2 years

  8. 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.

    Time frame: 2 years

07

Results

Posted Aug 17, 2012

Participant flow

Participant flow — Overall Study
Milestone11C-acetate for Prostate Cancer Patients
Started40
Completed39
Not completed1
Withdrew: Not imaged due to failed tracer imaging1

Outcome measures

PrimaryCompare 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.

Time frame:
2 years
Reported as:
Mean · ng/mL
Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate
ng/mL11C-acetate for Prostate Cancer Patients
Tumor region4.4 ± 2.05
Non-tumorous region2.1 ± 0.94
SecondaryCount 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.

Time frame:
2 years
Reported as:
Count of participants · Participants
Count of Participants With Adverse Events
Participants11C-acetate for Prostate Cancer Patients
Count of Participants With Adverse Events14
SecondaryDiagnostic 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.

Time frame:
2 years
Reported as:
Number · Percentage ROC curve
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
Percentage ROC curve11C-acetate for Prostate Cancer Patients
PET sensitivity62 (59 to 65)
MRI sensitivity82.3 (79 to 85)
PET specificity80 (78 to 82)
MRI specificity95 (92 to 97)
SecondaryPelvic 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).

Time frame:
2 years
Reported as:
Mean · SUV
Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging
SUV11C-acetate for Prostate Cancer Patients
Prostate tumor4.4 ± 2.05
Normal tumor2.1 ± 0.943
Benign prostatic hyperplasia (BPH)4.8 ± 2.01
Statistical analysis
  • 11C-acetate for Prostate Cancer Patients · Spearman rank correlation · p = <0.0001 (The reported p-value is representative of the difference in levels of the histopathologic confirmed tumor and normal prostate tissue.)
  • 11C-acetate for Prostate Cancer Patients · Spearman rank correlation · p = 0.65 (The reported p-value is representative of the BPH high uptake level.)
SecondaryCount 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.

Time frame:
2 years
Reported as:
Count of participants · Participants
Count of Participants With Physiological Effects of [11C]AC
Participants11C-acetate for Prostate Cancer Patients
Count of Participants With Physiological Effects of [11C]AC1
SecondaryIncidence 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.

Time frame:
2 years
Reported as:
Count of participants · Participants
Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection
Participants11C-acetate for Prostate Cancer Patients
Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection1
SecondaryStandardized 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.

Time frame:
2 years
Reported as:
Mean · SUV
Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score
SUV11C-acetate for Prostate Cancer Patients
Gleason scores 3+4 and below4.2 ± 1.8
Gleason scores 4+3 and above4.9 ± 3.1
Statistical analysis
  • 11C-acetate for Prostate Cancer Patients · Spearman rank correlation · p = 0.55
SecondaryLesion 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.

Time frame:
2 years
Reported as:
Number · percentage of sensitivity
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.
percentage of sensitivity11C-acetate for Prostate Cancer Patients
PET/CT73.4 (70 to 75)
MP-MRI88.5 (82 to 92)
DW-MRI80 (76 to 85)
DCE-MRI55 (50 to 61)
Secondary11C-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.

Time frame:
2 years
Reported as:
Mean · SUVmax
11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation
SUVmax11C-acetate for Prostate Cancer Patients
PSA level <4 ng/ml3.7 ± 2.0
PSA level 4-10 ng/ml4.9 ± 2.3
PSA level >10ng/ml5.1 ± 0.8
Statistical analysis
  • 11C-acetate for Prostate Cancer Patients · Spearman rank correlation · p = 0.407

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
11C-acetate for Prostate Cancer Patients0/40 (0%)0/40 (0%)14/40 (35%)
Most frequent other events
Most frequent other events
Event11C-acetate for Prostate Cancer Patients
Taste alteration (dysgeusia)Gastrointestinal disorders10/40
Constitutional Symptoms-Other (Specify, Funny smell)General disorders1/40
ConstipationGastrointestinal disorders1/40
NauseaGastrointestinal disorders1/40
VomitingGastrointestinal disorders1/40
Syncope (fainting)Nervous system disorders1/40
Pain: BackMusculoskeletal and connective tissue disorders1/40
Pain: Extremity-limbMusculoskeletal and connective tissue disorders1/40

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)11C-acetate for Prostate Cancer Patients
<=18 years0
Between 18 and 65 years33
>=65 years7
Age, Continuous
Age, Continuous(years)11C-acetate for Prostate Cancer Patients
Mean58.97 ± 6.11
Sex: Female, Male
Sex: Female, Male(Participants)11C-acetate for Prostate Cancer Patients
Female0
Male40
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)11C-acetate for Prostate Cancer Patients
Hispanic or Latino4
Not Hispanic or Latino36
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)11C-acetate for Prostate Cancer Patients
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American7
White28
More than one race0
Unknown or Not Reported3
Region of Enrollment
Region of Enrollment(participants)11C-acetate for Prostate Cancer Patients
United States40
Interval Between Magnetic Resonance Imaging and Prostatectomy
Interval Between Magnetic Resonance Imaging and Prostatectomy(Days)11C-acetate for Prostate Cancer Patients
Mean54 (2 to 155)
Days to Radical Prostatectomy
Days to Radical Prostatectomy(Days)11C-acetate for Prostate Cancer Patients
Mean10.5 (1 to 34)
08

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
09

References and documents

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 12679398 ↗
  • 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 ↗
  • Mena 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 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00924313
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Peter Choyke, M.D. (Principal Investigator, National Institutes of Health Clinical Center (CC)) — Principal investigator
First posted
Jun 18, 2009
Start date
Sep 10, 2008
Primary completion
Apr 19, 2011
Completion
Apr 19, 2011
Results posted
Aug 17, 2012
Last update
Jul 11, 2017

Study contacts

Peter L Choyke, M.D.
principal investigator · National Cancer Institute, National Institutes of Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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