Trial Outcomes & Findings for 18F-DCFBC PET/CT in Prostate Cancer (NCT NCT02190279)

NCT ID: NCT02190279

Last Updated: 2019-04-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

116 participants

Primary outcome timeframe

1 hour and 2 hour timepoints at baseline

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Suspected Localized Prostate Cancer 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.	Biochemical Recurrence 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.	Known Metastatic Disease 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 Study STARTED	16	69	31
Overall Study COMPLETED	13	69	28
Overall Study NOT COMPLETED	3	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Suspected Localized Prostate Cancer 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.	Known Metastatic Disease 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 Study Withdrawal consent	1	1
Overall Study Lost to Follow-up	2	0
Overall Study Refused further treatment	0	1
Overall Study Screening failure	0	1

Baseline Characteristics

18F-DCFBC PET/CT in Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suspected Localized Prostate Cancer n=16 Participants 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.	Biochemical Recurrence n=69 Participants 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.	Known Metastatic Disease n=31 Participants 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 n=116 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants	34 Participants n=107 Participants	14 Participants n=206 Participants	54 Participants n=157 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants	35 Participants n=107 Participants	17 Participants n=206 Participants	62 Participants n=157 Participants
Age, Continuous	64.58 years STANDARD_DEVIATION 8.53 • n=99 Participants	65.33 years STANDARD_DEVIATION 6.67 • n=107 Participants	63.93 years STANDARD_DEVIATION 11.41 • n=206 Participants	64.85 years STANDARD_DEVIATION 8.38 • n=157 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	69 Participants n=107 Participants	31 Participants n=206 Participants	116 Participants n=157 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=99 Participants	69 Participants n=107 Participants	31 Participants n=206 Participants	116 Participants n=157 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	3 Participants n=107 Participants	1 Participants n=206 Participants	4 Participants n=157 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants	7 Participants n=107 Participants	3 Participants n=206 Participants	14 Participants n=157 Participants
Race (NIH/OMB) White	12 Participants n=99 Participants	59 Participants n=107 Participants	27 Participants n=206 Participants	98 Participants n=157 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Region of Enrollment United States	16 Participants n=99 Participants	69 Participants n=107 Participants	31 Participants n=206 Participants	116 Participants n=157 Participants
Gleason Grade at Diagnosis Gleason Grade 5	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=157 Participants
Gleason Grade at Diagnosis Gleason Grade 6	3 Participants n=99 Participants	7 Participants n=107 Participants	7 Participants n=206 Participants	17 Participants n=157 Participants
Gleason Grade at Diagnosis Gleason Grade 7-8	9 Participants n=99 Participants	48 Participants n=107 Participants	11 Participants n=206 Participants	68 Participants n=157 Participants
Gleason Grade at Diagnosis Gleason Grade 9-10	3 Participants n=99 Participants	12 Participants n=107 Participants	9 Participants n=206 Participants	24 Participants n=157 Participants
Gleason Grade at Diagnosis Not available	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=157 Participants
Prior Prostate Cancer Therapy None	15 Participants n=99 Participants	0 Participants n=107 Participants	4 Participants n=206 Participants	19 Participants n=157 Participants
Prior Prostate Cancer Therapy Radical Prostatectomy	0 Participants n=99 Participants	49 Participants n=107 Participants	1 Participants n=206 Participants	50 Participants n=157 Participants
Prior Prostate Cancer Therapy Brachytherapy/Radiation	1 Participants n=99 Participants	8 Participants n=107 Participants	2 Participants n=206 Participants	11 Participants n=157 Participants
Prior Prostate Cancer Therapy ADT + Surgery or Radiation	0 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants	7 Participants n=157 Participants
Prior Prostate Cancer Therapy ADT + Chemotherapy	0 Participants n=99 Participants	0 Participants n=107 Participants	7 Participants n=206 Participants	7 Participants n=157 Participants
Prior Prostate Cancer Therapy ADT	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=157 Participants
Prior Prostate Cancer Therapy Combo radical prostectomy and radiation therapy	0 Participants n=99 Participants	9 Participants n=107 Participants	8 Participants n=206 Participants	17 Participants n=157 Participants
Prior Prostate Cancer Therapy Unknown	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=157 Participants
Baseline Imaging NaF PET/CT	13 Participants n=99 Participants	0 Participants n=107 Participants	28 Participants n=206 Participants	41 Participants n=157 Participants
Baseline Imaging DCFBC(1h) PET/CT	13 Participants n=99 Participants	68 Participants n=107 Participants	28 Participants n=206 Participants	109 Participants n=157 Participants
Baseline Imaging DCFBC(2h) PET/CT	13 Participants n=99 Participants	68 Participants n=107 Participants	27 Participants n=206 Participants	108 Participants n=157 Participants
Prostatic-Specific Antigen (PSA) at Baseline	37.5 ng/ml n=99 Participants	1.63 ng/ml n=107 Participants	1.90 ng/ml n=206 Participants	13.67 ng/ml n=157 Participants
Castration Status Untreated	0 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=157 Participants
Castration Status Castrate-sensitive	0 Participants n=99 Participants	0 Participants n=107 Participants	14 Participants n=206 Participants	14 Participants n=157 Participants
Castration Status Castrate-resistant	0 Participants n=99 Participants	0 Participants n=107 Participants	11 Participants n=206 Participants	11 Participants n=157 Participants

PRIMARY outcome

Timeframe: 1 hour and 2 hour timepoints at baseline

Population: 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

Outcome measures

Outcome measures
Measure	Suspected Localized Prostate Cancer n=13 Participants 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.	Biochemical Recurrence n=68 Participants 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.	Known Metastatic Disease n=28 Participants 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.
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 Lymph nodes	1 Participants	39 Participants	28 Participants
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 Distant sites	0 Participants	10 Participants	10 Participants
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 Prostate bed/anastomosis	8 Participants	30 Participants	28 Participants

PRIMARY outcome

Timeframe: 1 hour and 2 hour timepoints at baseline

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.

Outcome measures

Outcome measures
Measure	Suspected Localized Prostate Cancer n=13 Participants 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.	Biochemical Recurrence n=68 Participants 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.	Known Metastatic Disease n=28 Participants 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.
Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)	9 lesions	79 lesions	140 lesions

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 42 months and 21 days

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.

Outcome measures

Outcome measures
Measure	Suspected Localized Prostate Cancer n=16 Participants 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.	Biochemical Recurrence n=69 Participants 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.	Known Metastatic Disease n=31 Participants 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.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)	1 Participants	3 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 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.

18F-DFBC and conventional imaging was used to identify positive lesions in bone.

Outcome measures

Outcome measures
Measure	Suspected Localized Prostate Cancer n=241 lesions 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.	Biochemical Recurrence 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.	Known Metastatic Disease 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.
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	185 number of bone lesions	—	—

SECONDARY outcome

Timeframe: 1 hour and 2 hour post injection (p.i.)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Suspected Localized Prostate Cancer n=13 Participants 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.	Biochemical Recurrence 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.	Known Metastatic Disease 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.
Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH) Primary prostate tumor - 1 hour post injection	5.8 standardized uptake value (SUV) Standard Deviation 4.4	—	—
Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH) BPH nodules - 1 hour post injection	2.1 standardized uptake value (SUV) Standard Deviation 0.3	—	—
Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH) Normal prostate - 1 hour post injection	2.1 standardized uptake value (SUV) Standard Deviation 0.4	—	—
Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH) Primary prostate tumor - 2 hour post injection	5.9 standardized uptake value (SUV) Standard Deviation 5.3	—	—
Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH) BPH nodules - 2 hour post injection	2.0 standardized uptake value (SUV) Standard Deviation 0.36	—	—
Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH) Normal prostate tumor - 2 hour post injection	2.0 standardized uptake value (SUV) Standard Deviation 0.28	—	—

SECONDARY outcome

Timeframe: 1 month

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Suspected Localized Prostate Cancer n=25 Tumor foci 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.	Biochemical Recurrence 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.	Known Metastatic Disease 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.
Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy	1.5 cm Interval 0.6 to 4.7	—	—

SECONDARY outcome

Timeframe: 3 months

Visualizing positive lesions with DCFBC and mpMRI.

Outcome measures

Outcome measures
Measure	Suspected Localized Prostate Cancer n=25 lesions 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.	Biochemical Recurrence 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.	Known Metastatic Disease 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.
Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland 18F-DCFBC	36 percent of lesions identified	—	—
Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland mpMRI	96 percent of lesions identified	—	—

SECONDARY outcome

Timeframe: 3 months

Population: 1 patient had technical issues and was not included in the final analysis.

Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.

Outcome measures

Outcome measures
Measure	Suspected Localized Prostate Cancer n=68 Participants 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.	Biochemical Recurrence 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.	Known Metastatic Disease 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.
Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group <0.5 ng/mL	15 percent of tumors identified	—	—
Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group 0.5 to <1.0 ng/mL	46 percent of tumors identified	—	—
Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group 1.0 to 2.0 ng/mL	83 percent of tumors identified	—	—
Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group 2.0 ng/mL	77 percent of tumors identified	—	—

Adverse Events

Suspected Localized Prostate Cancer

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Biochemical Recurrence

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Known Metastatic Disease

Serious events: 4 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Suspected Localized Prostate Cancer n=16 participants at risk 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.	Biochemical Recurrence n=69 participants at risk 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.	Known Metastatic Disease n=31 participants at risk 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.
Gastrointestinal disorders Gastrointestinal disorders - Other, nausea	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	1.4% 1/69 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/31 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Vascular disorders Thromboembolic event	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	1.4% 1/69 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/31 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
General disorders Death NOS	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	6.5% 2/31 • Number of events 2 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.

Other adverse events

Other adverse events
Measure	Suspected Localized Prostate Cancer n=16 participants at risk 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.	Biochemical Recurrence n=69 participants at risk 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.	Known Metastatic Disease n=31 participants at risk 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.
General disorders Pain	6.2% 1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	1.4% 1/69 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/31 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
General disorders Fever	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	1.4% 1/69 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/31 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Renal and urinary disorders Urinary retention	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	1.4% 1/69 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/31 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Renal and urinary disorders Urinary tract pain	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	1.4% 1/69 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/31 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Renal and urinary disorders Urinary urgency	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	1.4% 1/69 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/31 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Investigations Alkaline phosphatase increased	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Blood and lymphatic system disorders Anemia	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	6.5% 2/31 • Number of events 2 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Investigations Blood bilirubin increased	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Investigations Investigations - Other, near syncope	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Investigations Lymphocyte count increased	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	3.2% 1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 42 months and 21 days.
Investigations Platelet count decreased	0.00% 0/16 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	0.00% 0/69 • Date treatment consent signed to date off study, approximately 42 months and 21 days.	6.5% 2/31 • Number of events 2 • Date treatment consent signed to date off study, approximately 42 months and 21 days.

Additional Information

Dr. Maria Liza Lindenberg

National Cancer Institute

Phone: 240-760-6109

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place