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Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01815515
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Metastatic Prostate Cancer
Intervention Drug: 18F-DCFBC
Enrollment 22
Recruitment Details  
Pre-assignment Details 22 participants enrolled, 5 screen failures, therefore only 17 participants started the study.
Arm/Group Title 18F-DCFBC
Hide Arm/Group Description Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
Period Title: Overall Study
Started 17
Completed 17
Not Completed 0
Arm/Group Title 18F-DCFBC
Hide Arm/Group Description Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
68.4  (7.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
0
   0.0%
Male
17
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
 100.0%
Prostate specific antigen (PSA)  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 17 participants
95.6  (141.26)
Serum folate  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Normal range (2.5-20 ng/mL)
11
  64.7%
21-24 ng/mL
1
   5.9%
High (>24 ng/mL)
5
  29.4%
Red cell folate   [1] [2] 
Mean (Full Range)
Unit of measure:  ng/mL
Number Analyzed 13 participants
550.69
(268 to 1049)
[1]
Measure Description: Normal range = 160-855 ng/mL
[2]
Measure Analysis Population Description: Data was not available in 4 participants
Testosterone <20 ng/mL  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
8
  47.1%
Testosterone   [1] 
Mean (Full Range)
Unit of measure:  ng/mL
Number Analyzed 9 participants
396.33
(245 to 746)
[1]
Measure Analysis Population Description: Mean testosterone level (ng/mL) for participants with values other than "<20 ng/mL"
Prior prostate cancer therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Prostatectomy Number Analyzed 17 participants
7
  41.2%
Androgen deprivation Number Analyzed 17 participants
8
  47.1%
Docetaxel Number Analyzed 17 participants
2
  11.8%
Tasquinimod Number Analyzed 17 participants
1
   5.9%
Abiraterone Number Analyzed 17 participants
1
   5.9%
External-beam radiation to the pelvis Number Analyzed 17 participants
7
  41.2%
External-beam radiation to the right hip Number Analyzed 17 participants
1
   5.9%
External-beam radiation to the spine Number Analyzed 17 participants
1
   5.9%
Prostate brachytherapy Number Analyzed 17 participants
1
   5.9%
Radium-223 (223Ra) Number Analyzed 17 participants
1
   5.9%
None Number Analyzed 17 participants
1
   5.9%
1.Primary Outcome
Title Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)
Hide Description Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Combined Imaging Modality (CIM) refers to both CT and BS imaging. The total number of lesions analyzed by both CT and BS (CIM) are 235 (as represented by PET-positive and PET-negative, equivocal CIM). There is overlap in the number of lesions detected by conventional imaging modalities (ie: bone scan and computed tomography)
Arm/Group Title 18F-DCFBC
Hide Arm/Group Description:
Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
Overall Number of Participants Analyzed 17
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
235
Measure Type: Number
Unit of Measure: lesions detected
PET Positive, CT negative/equivocal Number Analyzed 170 Lesions
148
PET Positive, BS negative/equivocal Number Analyzed 170 Lesions
170
PET Positive, Combined CIM negative/equivocal Number Analyzed 235 Lesions
170
PET negative/equivocal, CT positive Number Analyzed 55 Lesions
50
PET negative/equivocal, BS positive Number Analyzed 55 Lesions
14
PET negative/equivocal, Combined CIM positive Number Analyzed 235 Lesions
55
2.Secondary Outcome
Title Sensitivity of Detection of New or Progression of Metastasis
Hide Description Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where "equivocal" lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed.
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Follow-up CIM was only available for 12 of the 17 participants. 92% of the lesions detected via 18F-DCFBC PET were marked as true positive.
Arm/Group Title 18F-DCFBC
Hide Arm/Group Description:
Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography [CECT] and bone scintigraphy [BS]) undergo PET imaging with 18F-DCFBC radiotracer.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of responsive lesions
18F-DCFBC PET
0.92
(0.80 to 0.97)
CECT
0.64
(0.41 to 0.82)
BS
0.40
(0.20 to 0.65)
Combined CIM (BS and CECT)
0.71
(0.49 to 0.86)
Time Frame Up to 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18F-DCFBC
Hide Arm/Group Description 18F-DCFBC
All-Cause Mortality
18F-DCFBC
Affected / at Risk (%)
Total   0/17 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
18F-DCFBC
Affected / at Risk (%) # Events
Total   0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
18F-DCFBC
Affected / at Risk (%) # Events
Total   4/17 (23.53%)    
Gastrointestinal disorders   
Blood in stool *  1/17 (5.88%)  1
Nervous system disorders   
Headache   1/17 (5.88%)  1
Skin and subcutaneous tissue disorders   
Rash *  1/17 (5.88%)  1
Vascular disorders   
Hypertension *  3/17 (17.65%)  3
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Rowe, M.D, Ph.D
Organization: Johns Hopkins University
Phone: 4105021520
EMail: srowe8@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01815515     History of Changes
Other Study ID Numbers: J12113
NA_00052383 ( Other Identifier: JHM IRB )
First Submitted: March 18, 2013
First Posted: March 21, 2013
Results First Submitted: July 11, 2018
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018