Trial Outcomes & Findings for Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer (NCT NCT01815515)

Last Updated: 2018-08-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

24 Months

Results posted on

2018-08-20

Participant Flow

22 participants enrolled, 5 screen failures, therefore only 17 participants started the study.

Participant milestones

Participant milestones
Measure	18F-DCFBC 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 Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18F-DCFBC n=17 Participants 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.
Age, Continuous	68.4 years STANDARD_DEVIATION 7.89 • n=17 Participants
Sex: Female, Male Female	0 Participants n=17 Participants
Sex: Female, Male Male	17 Participants n=17 Participants
Region of Enrollment United States	17 Participants n=17 Participants
Prostate specific antigen (PSA)	95.6 ng/mL STANDARD_DEVIATION 141.26 • n=17 Participants
Serum folate Normal range (2.5-20 ng/mL)	11 Participants n=17 Participants
Serum folate 21-24 ng/mL	1 Participants n=17 Participants
Serum folate High (>24 ng/mL)	5 Participants n=17 Participants
Red cell folate	550.69 ng/mL n=13 Participants • Data was not available in 4 participants
Testosterone <20 ng/mL	8 Participants n=17 Participants
Testosterone	396.33 ng/mL n=9 Participants • Mean testosterone level (ng/mL) for participants with values other than "\<20 ng/mL"
Prior prostate cancer therapy Prostatectomy	7 Participants n=17 Participants
Prior prostate cancer therapy Androgen deprivation	8 Participants n=17 Participants
Prior prostate cancer therapy Docetaxel	2 Participants n=17 Participants
Prior prostate cancer therapy Tasquinimod	1 Participants n=17 Participants
Prior prostate cancer therapy Abiraterone	1 Participants n=17 Participants
Prior prostate cancer therapy External-beam radiation to the pelvis	7 Participants n=17 Participants
Prior prostate cancer therapy External-beam radiation to the right hip	1 Participants n=17 Participants
Prior prostate cancer therapy External-beam radiation to the spine	1 Participants n=17 Participants
Prior prostate cancer therapy Prostate brachytherapy	1 Participants n=17 Participants
Prior prostate cancer therapy Radium-223 (223Ra)	1 Participants n=17 Participants
Prior prostate cancer therapy None	1 Participants n=17 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: 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)

Outcome measures

Outcome measures
Measure	18F-DCFBC n=235 Lesions 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.
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) PET Positive, CT negative/equivocal	148 lesions detected
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) PET Positive, BS negative/equivocal	170 lesions detected
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) PET Positive, Combined CIM negative/equivocal	170 lesions detected
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) PET negative/equivocal, CT positive	50 lesions detected
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) PET negative/equivocal, BS positive	14 lesions detected
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) PET negative/equivocal, Combined CIM positive	55 lesions detected

SECONDARY outcome

Timeframe: up to 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	18F-DCFBC n=12 Participants 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.
Sensitivity of Detection of New or Progression of Metastasis 18F-DCFBC PET	0.92 proportion of responsive lesions Interval 0.8 to 0.97
Sensitivity of Detection of New or Progression of Metastasis CECT	0.64 proportion of responsive lesions Interval 0.41 to 0.82
Sensitivity of Detection of New or Progression of Metastasis BS	0.40 proportion of responsive lesions Interval 0.2 to 0.65
Sensitivity of Detection of New or Progression of Metastasis Combined CIM (BS and CECT)	0.71 proportion of responsive lesions Interval 0.49 to 0.86

Adverse Events

18F-DCFBC

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	18F-DCFBC n=17 participants at risk 18F-DCFBC
Nervous system disorders Headache	5.9% 1/17 • Number of events 1 • Up to 1 month
Vascular disorders Hypertension	17.6% 3/17 • Number of events 3 • Up to 1 month
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • Number of events 1 • Up to 1 month
Gastrointestinal disorders Blood in stool	5.9% 1/17 • Number of events 1 • Up to 1 month

Additional Information

Steven Rowe, M.D, Ph.D

Johns Hopkins University

Phone: 4105021520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place