Trial Outcomes & Findings for Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer (NCT NCT01496157)

Last Updated: 2018-08-28

Results Overview

To compare number of participants with positive or negative uptake of 18F-DCFBC in primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score \> 4+3=7).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

24 months

Results posted on

2018-08-28

Participant Flow

2 enrolled participants were screen failures, therefore 13 started the study.

Participant milestones

Participant milestones
Measure	Patients With Primary Prostate Cancer Patients will be imaged with 18F-DCFBC 18F-DCFBC: A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.
Overall Study STARTED	13
Overall Study COMPLETED	13
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	Patients With Primary Prostate Cancer n=13 Participants Patients will be imaged with 18F-DCFBC 18F-DCFBC: A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=13 Participants
Age, Categorical >=65 years	4 Participants n=13 Participants
Sex: Female, Male Female	0 Participants n=13 Participants
Sex: Female, Male Male	13 Participants n=13 Participants
Region of Enrollment United States	13 participants n=13 Participants
Prostate specific antigen (PSA)	8.36 ng/mL STANDARD_DEVIATION 3.77 • n=13 Participants
Biopsy Gleason Score Gleason score 3+3	1 Participants n=13 Participants
Biopsy Gleason Score Gleason Score 3+4	5 Participants n=13 Participants
Biopsy Gleason Score Gleason Score 4+3	4 Participants n=13 Participants
Biopsy Gleason Score Gleason Score 4+4	3 Participants n=13 Participants
Prostatectomy gleason score Gleason 3+3	1 Participants n=13 Participants
Prostatectomy gleason score Gleason 3+4	5 Participants n=13 Participants
Prostatectomy gleason score Gleason 4+3	2 Participants n=13 Participants
Prostatectomy gleason score Gleason 4+4	1 Participants n=13 Participants
Prostatectomy gleason score Gleason 4+5	3 Participants n=13 Participants
Prostatectomy gleason score Gleason 5+3	1 Participants n=13 Participants

PRIMARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	Patients With Primary Prostate Cancer n=13 Participants Patients will be imaged with 18F-DCFBC 18F-DCFBC: A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.
PET Detection of Primary Prostate Cancer Prostate Cancer with Positive Uptake of 18F-DCFBC	6 Participants
PET Detection of Primary Prostate Cancer Prostate Cancer with Negative Uptake of 18F-DCFBC	7 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Data was not collected for this outcome measure.

To compare the detection of bone and nodal metastatic disease by DCFBC PET at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and biopsy pathology.

Outcome measures

Outcome data not reported

Adverse Events

Patients With Primary Prostate Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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