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18F-DCFBC PET/CT in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02190279
Recruitment Status : Completed
First Posted : July 15, 2014
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Liza Lindenberg, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Prostatic Neoplasms
Prostate Cancer
Interventions Drug: 18F DCFBC
Drug: Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)
Enrollment 116
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease
Hide Arm/Group Description

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Period Title: Overall Study
Started 16 69 31
Completed 13 69 28
Not Completed 3 0 3
Reason Not Completed
Withdrawal consent             1             0             1
Lost to Follow-up             2             0             0
Refused further treatment             0             0             1
Screening failure             0             0             1
Arm/Group Title Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease Total
Hide Arm/Group Description

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Total of all reporting groups
Overall Number of Baseline Participants 16 69 31 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 69 participants 31 participants 116 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  37.5%
34
  49.3%
14
  45.2%
54
  46.6%
>=65 years
10
  62.5%
35
  50.7%
17
  54.8%
62
  53.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 69 participants 31 participants 116 participants
64.58  (8.53) 65.33  (6.67) 63.93  (11.41) 64.85  (8.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 69 participants 31 participants 116 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
16
 100.0%
69
 100.0%
31
 100.0%
116
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 69 participants 31 participants 116 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
16
 100.0%
69
 100.0%
31
 100.0%
116
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 69 participants 31 participants 116 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
   4.3%
1
   3.2%
4
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  25.0%
7
  10.1%
3
   9.7%
14
  12.1%
White
12
  75.0%
59
  85.5%
27
  87.1%
98
  84.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 69 participants 31 participants 116 participants
16
 100.0%
69
 100.0%
31
 100.0%
116
 100.0%
Gleason Grade at Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 69 participants 31 participants 116 participants
Gleason Grade 5
1
   6.3%
1
   1.4%
0
   0.0%
2
   1.7%
Gleason Grade 6
3
  18.8%
7
  10.1%
7
  22.6%
17
  14.7%
Gleason Grade 7-8
9
  56.3%
48
  69.6%
11
  35.5%
68
  58.6%
Gleason Grade 9-10
3
  18.8%
12
  17.4%
9
  29.0%
24
  20.7%
Not available
0
   0.0%
1
   1.4%
1
   3.2%
2
   1.7%
[1]
Measure Description: Gleason grades help determine a good or bad prognosis for a with prostate cancer. Grade 5-6 are low on the scale and can indicate a less aggressive cancer. A higher number such as Grade 7-10 means a more aggressive cancer.
Prior Prostate Cancer Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 69 participants 31 participants 116 participants
None
15
  93.8%
0
   0.0%
4
  12.9%
19
  16.4%
Radical Prostatectomy
0
   0.0%
49
  71.0%
1
   3.2%
50
  43.1%
Brachytherapy/Radiation
1
   6.3%
8
  11.6%
2
   6.5%
11
   9.5%
ADT + Surgery or Radiation
0
   0.0%
2
   2.9%
5
  16.1%
7
   6.0%
ADT + Chemotherapy
0
   0.0%
0
   0.0%
7
  22.6%
7
   6.0%
ADT
0
   0.0%
0
   0.0%
1
   3.2%
1
   0.9%
Combo radical prostectomy and radiation therapy
0
   0.0%
9
  13.0%
8
  25.8%
17
  14.7%
Unknown
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.9%
[1]
Measure Description: Androgen deprivation therapy (ADT). Radium 223 (Ra223).
Baseline Imaging   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 69 participants 31 participants 116 participants
NaF PET/CT
13
  81.3%
0
   0.0%
28
  90.3%
41
  35.3%
DCFBC(1h) PET/CT
13
  81.3%
68
  98.6%
28
  90.3%
109
  94.0%
DCFBC(2h) PET/CT
13
  81.3%
68
  98.6%
27
  87.1%
108
  93.1%
[1]
Measure Description: N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Positron emission tomography (PET) Computed tomography (CT)
Prostatic-Specific Antigen (PSA) at Baseline   [1] 
Median (Full Range)
Unit of measure:  Ng/ml
Number Analyzed 16 participants 69 participants 31 participants 116 participants
37.5
(3.26 to 216)
1.63
(0.2 to 37.4)
1.90
(0.01 to 4379)
13.67
(1.15 to 1544)
[1]
Measure Description: Normal PSA is defined as less than 4.0 ng/ml.
Castration Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 69 participants 31 participants 116 participants
Untreated
0
   0.0%
0
   0.0%
3
   9.7%
3
   2.6%
Castrate-sensitive
0
   0.0%
0
   0.0%
14
  45.2%
14
  12.1%
Castrate-resistant
0
   0.0%
0
   0.0%
11
  35.5%
11
   9.5%
[1]
Measure Description: Castrate sensitive is defined as cancer that is outside the boundary of the prostate. Castrate resistant is defined as cancer of the prostate that no longer responds to one of the most common types of prostate treatment known as androgen deprivation therapy (ADT) (i.e. lowers testosterone levels).
1.Primary Outcome
Title Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging
Hide Description Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.
Time Frame 1 hour and 2 hour timepoints at baseline
Hide Outcome Measure Data
Hide Analysis Population Description

In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue.

Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent

Arm/Group Title Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease
Hide Arm/Group Description:

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Overall Number of Participants Analyzed 13 68 28
Measure Type: Count of Participants
Unit of Measure: Participants
Lymph nodes
1
   7.7%
39
  57.4%
28
 100.0%
Distant sites
0
   0.0%
10
  14.7%
10
  35.7%
Prostate bed/anastomosis
8
  61.5%
30
  44.1%
28
 100.0%
2.Primary Outcome
Title Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
Hide Description Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.
Time Frame 1 hour and 2 hour timepoints at baseline
Hide Outcome Measure Data
Hide Analysis Population Description

In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue.

Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent

Arm/Group Title Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease
Hide Arm/Group Description:

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Overall Number of Participants Analyzed 13 68 28
Measure Type: Number
Unit of Measure: lesions
9 79 140
3.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 42 months and 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease
Hide Arm/Group Description:

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Overall Number of Participants Analyzed 16 69 31
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.3%
3
   4.3%
8
  25.8%
4.Secondary Outcome
Title Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease
Hide Description 18F-DFBC and conventional imaging was used to identify positive lesions in bone.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Suspected Localized Prostate Cancer and Biochemical Recurrence Arms/Groups are not applicable for this outcome measure, thus are not represented here. Data was collected for 31 participants but only 28 had data evaluable for final analysis in the Known Metastatic Group.
Arm/Group Title Known Metastatic Disease
Hide Arm/Group Description:

Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
241
Measure Type: Number
Unit of Measure: number of bone lesions
185
5.Secondary Outcome
Title Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)
Hide Description Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes.
Time Frame 1 hour and 2 hour post injection (p.i.)
Hide Outcome Measure Data
Hide Analysis Population Description
3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue. The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.
Arm/Group Title Suspected Localized Prostate Cancer
Hide Arm/Group Description:

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
Primary prostate tumor - 1 hour post injection 5.8  (4.4)
BPH nodules - 1 hour post injection 2.1  (0.3)
Normal prostate - 1 hour post injection 2.1  (0.4)
Primary prostate tumor - 2 hour post injection 5.9  (5.3)
BPH nodules - 2 hour post injection 2.0  (0.36)
Normal prostate tumor - 2 hour post injection 2.0  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Suspected Localized Prostate Cancer
Comments At 1 hour post injection.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Suspected Localized Prostate Cancer
Comments At 2 hour post injection.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy
Hide Description Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.
Arm/Group Title Suspected Localized Prostate Cancer
Hide Arm/Group Description:

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Overall Number of Participants Analyzed 13
Overall Number of Units Analyzed
Type of Units Analyzed: Tumor foci
25
Median (Full Range)
Unit of Measure: cm
1.5
(0.6 to 4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Suspected Localized Prostate Cancer
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments One way analysis variance.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method variance
Comments [Not Specified]
7.Secondary Outcome
Title Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland
Hide Description Visualizing positive lesions with DCFBC and mpMRI.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.
Arm/Group Title Suspected Localized Prostate Cancer
Hide Arm/Group Description:

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Overall Number of Participants Analyzed 13
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
25
Measure Type: Number
Unit of Measure: percent of lesions identified
18F-DCFBC 36
mpMRI 96
8.Secondary Outcome
Title Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group
Hide Description Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient had technical issues and was not included in the final analysis.
Arm/Group Title Biochemical Recurrence
Hide Arm/Group Description:

Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Overall Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percent of tumors identified
<0.5 ng/mL 15
0.5 to <1.0 ng/mL 46
1.0 to 2.0 ng/mL 83
2.0 ng/mL 77
Time Frame Date treatment consent signed to date off study, approximately 42 months and 21 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease
Hide Arm/Group Description

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

All-Cause Mortality
Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/69 (0.00%)      2/31 (6.45%)    
Show Serious Adverse Events Hide Serious Adverse Events
Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      1/69 (1.45%)      4/31 (12.90%)    
Gastrointestinal disorders       
Gastrointestinal disorders - Other, nausea  1  0/16 (0.00%)  0 1/69 (1.45%)  1 0/31 (0.00%)  0
General disorders       
Death NOS  1  0/16 (0.00%)  0 0/69 (0.00%)  0 2/31 (6.45%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death  1  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [1]  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Vascular disorders       
Thromboembolic event  1  0/16 (0.00%)  0 1/69 (1.45%)  1 0/31 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Death due to progressive disease
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Suspected Localized Prostate Cancer Biochemical Recurrence Known Metastatic Disease
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      3/69 (4.35%)      8/31 (25.81%)    
Blood and lymphatic system disorders       
Anemia  1  0/16 (0.00%)  0 0/69 (0.00%)  0 2/31 (6.45%)  2
General disorders       
Pain  1  1/16 (6.25%)  1 1/69 (1.45%)  1 0/31 (0.00%)  0
Fever  1  0/16 (0.00%)  0 1/69 (1.45%)  1 0/31 (0.00%)  0
Investigations       
Alkaline phosphatase increased  1  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Blood bilirubin increased  1  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Investigations - Other, near syncope  1  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Lymphocyte count increased  1  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Platelet count decreased  1  0/16 (0.00%)  0 0/69 (0.00%)  0 2/31 (6.45%)  2
Metabolism and nutrition disorders       
Hyperkalemia  1  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Hypernatremia  1  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Hypophosphatemia  1  0/16 (0.00%)  0 0/69 (0.00%)  0 1/31 (3.23%)  1
Renal and urinary disorders       
Urinary retention  1  0/16 (0.00%)  0 1/69 (1.45%)  1 0/31 (0.00%)  0
Urinary tract pain  1  0/16 (0.00%)  0 1/69 (1.45%)  1 0/31 (0.00%)  0
Urinary urgency  1  0/16 (0.00%)  0 1/69 (1.45%)  1 0/31 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Maria Liza Lindenberg
Organization: National Cancer Institute
Phone: 240-760-6109
Responsible Party: Maria Liza Lindenberg, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02190279     History of Changes
Other Study ID Numbers: 140140
14-C-0140
First Submitted: July 12, 2014
First Posted: July 15, 2014
Results First Submitted: December 21, 2018
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019