NCT04186819 · BASELINE

Baseline characteristics

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer. · Source last updated 2025-02-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
356
units
Participants

groups

description
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron Emission Tomography scan: imaging test with radioligand
id
BG000
title
Single Arm

measures

classes
categories
measurements
group Id
BG000
spread
6.98
value
64.9
denoms
counts
group Id
BG000
value
356
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
163
denoms
counts
group Id
BG000
value
356
units
Participants
title
< 65 years
categories
measurements
group Id
BG000
value
193
denoms
counts
group Id
BG000
value
356
units
Participants
title
≥ 65 years
description
Age in years split into 2 groups
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
0
title
Female
measurements
group Id
BG000
value
356
title
Male
denoms
counts
group Id
BG000
value
356
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
17
title
Hispanic or Latino
measurements
group Id
BG000
value
311
title
Not Hispanic or Latino
measurements
group Id
BG000
value
28
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
356
units
Participants
description
Ethnicity split into 2 substantive groups and those for whom it was not reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
30
denoms
counts
group Id
BG000
value
356
units
Participants
title
Black or African American
categories
measurements
group Id
BG000
value
289
denoms
counts
group Id
BG000
value
356
units
Participants
title
White
categories
measurements
group Id
BG000
value
4
denoms
counts
group Id
BG000
value
356
units
Participants
title
Other
categories
measurements
group Id
BG000
value
33
denoms
counts
group Id
BG000
value
356
units
Participants
title
Not Reported
description
Race split into 3 substantive categories and also those for whom it was not reported
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
14
denoms
counts
group Id
BG000
value
356
units
Participants
title
Netherlands
categories
measurements
group Id
BG000
value
238
denoms
counts
group Id
BG000
value
356
units
Participants
title
United States
categories
measurements
group Id
BG000
value
18
denoms
counts
group Id
BG000
value
356
units
Participants
title
Finland
categories
measurements
group Id
BG000
value
86
denoms
counts
group Id
BG000
value
356
units
Participants
title
Germany
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
160
denoms
counts
group Id
BG000
value
356
units
Participants
title
=7
categories
measurements
group Id
BG000
value
87
denoms
counts
group Id
BG000
value
356
units
Participants
title
=8
categories
measurements
group Id
BG000
value
97
denoms
counts
group Id
BG000
value
356
units
Participants
title
=9
categories
measurements
group Id
BG000
value
6
denoms
counts
group Id
BG000
value
356
units
Participants
title
=10
categories
measurements
group Id
BG000
value
6
denoms
counts
group Id
BG000
value
356
units
Participants
title
≤ 6
description
Gleason score (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Score 6 - The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Score 7 - Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Score 8 - Some cells look abnormal. The cancer might grow quickly or at a moderate rate Score 9 or 10 - The cells look very abnormal. The cancer is likely to grow quickly
param Type
NUMBER
title
Total Gleason Score
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
16
denoms
counts
group Id
BG000
value
356
units
Participants
title
T1
categories
measurements
group Id
BG000
value
2
denoms
counts
group Id
BG000
value
356
units
Participants
title
T1a
categories
measurements
group Id
BG000
value
127
denoms
counts
group Id
BG000
value
356
units
Participants
title
T1c
categories
measurements
group Id
BG000
value
58
denoms
counts
group Id
BG000
value
356
units
Participants
title
T2
categories
measurements
group Id
BG000
value
18
denoms
counts
group Id
BG000
value
356
units
Participants
title
T2a
categories
measurements
group Id
BG000
value
25
denoms
counts
group Id
BG000
value
356
units
Participants
title
T2b
categories
measurements
group Id
BG000
value
33
denoms
counts
group Id
BG000
value
356
units
Participants
title
T2c
categories
measurements
group Id
BG000
value
20
denoms
counts
group Id
BG000
value
356
units
Participants
title
T3
categories
measurements
group Id
BG000
value
21
denoms
counts
group Id
BG000
value
356
units
Participants
title
T3a
categories
measurements
group Id
BG000
value
12
denoms
counts
group Id
BG000
value
356
units
Participants
title
T3b
categories
measurements
group Id
BG000
value
1
denoms
counts
group Id
BG000
value
356
units
Participants
title
T3c
categories
measurements
group Id
BG000
value
2
denoms
counts
group Id
BG000
value
356
units
Participants
title
T4
description
Tumour (T) describes the size or area of the cancer T1 means the cancer is too small to be seen on a scan, or felt during an examination of the prostate T1a means that the cancer is in less than 5% of the removed tissue T1c cancers are found by biopsy, for example after a raised PSA level T2 means the cancer is completely inside the prostate gland T3a means the cancer has broken through the capsule (covering) of the prostate gland T3b means the cancer has spread into the tubes that carry semen (seminal vesicles) T4 means the cancer has spread into other body organs nearby
param Type
NUMBER
title
TNM (Tumor-Node-Metastasis) Stage T
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
6
denoms
counts
group Id
BG000
value
356
units
Participants
title
=1
categories
measurements
group Id
BG000
value
50
denoms
counts
group Id
BG000
value
356
units
Participants
title
=2
categories
measurements
group Id
BG000
value
110
denoms
counts
group Id
BG000
value
356
units
Participants
title
=3
categories
measurements
group Id
BG000
value
87
denoms
counts
group Id
BG000
value
356
units
Participants
title
=4
categories
measurements
group Id
BG000
value
103
denoms
counts
group Id
BG000
value
356
units
Participants
title
=5
description
GGG (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Group 1: The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Group 2: Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Group 3: The cells look less like normal prostate cells. The cancer is likely to grow at a moderate rate Group 4: Some cells look abnormal. The cancer might grow quickly or at a moderate rate Group 5: The cells look very abnormal. The cancer is likely to grow quickly
param Type
NUMBER
title
Gleason Grade Group (GGG)
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
290
denoms
counts
group Id
BG000
value
356
units
Participants
title
M0
categories
measurements
group Id
BG000
value
4
denoms
counts
group Id
BG000
value
356
units
Participants
title
M1
categories
measurements
group Id
BG000
value
1
denoms
counts
group Id
BG000
value
356
units
Participants
title
M1a
categories
measurements
group Id
BG000
value
1
denoms
counts
group Id
BG000
value
356
units
Participants
title
M1b
categories
measurements
group Id
BG000
value
48
denoms
counts
group Id
BG000
value
356
units
Participants
title
MX
categories
measurements
group Id
BG000
value
12
denoms
counts
group Id
BG000
value
356
units
Participants
title
Missing
description
Metastasis (M) describes whether the cancer has spread to a different part of the body. M0 means the cancer hasn't spread to other parts of your body. M1 means the cancer has spread to other parts of the body outside the pelvis. It is split into M1a, M1b and M1c. M1a means there are cancer cells in lymph nodes outside the pelvis M1b means there are cancer cells in the bone M1c means there are cancer cells in other parts of the body such as the lungs
param Type
NUMBER
title
TNM Stage M
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
2
denoms
counts
group Id
BG000
value
356
units
Participants
title
>1.0 to 2.0
categories
measurements
group Id
BG000
value
62
denoms
counts
group Id
BG000
value
356
units
Participants
title
>2.0 to 5.0
categories
measurements
group Id
BG000
value
134
denoms
counts
group Id
BG000
value
356
units
Participants
title
>5.0 to 10.0
categories
measurements
group Id
BG000
value
158
denoms
counts
group Id
BG000
value
356
units
Participants
title
>10.0
param Type
NUMBER
title
Prostate-specific antigen (PSA) Characterization (ng/mL)
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
241
denoms
counts
group Id
BG000
value
356
units
Participants
title
High-risk or Veryhigh-risk
categories
measurements
group Id
BG000
value
115
denoms
counts
group Id
BG000
value
356
units
Participants
title
Immediate-Risk
description
Baseline Risk Category. High-risk or Very-high risk defined as meeting any one of these criteria: T-stage T3 (including T3a and T3b) or T4, GGG 4 or 5, Primary Gleason pattern 5, or PSA \>20 ng/mL.
param Type
NUMBER
title
Baseline Risk Category
unit Of Measure
participants

population Description

The FAS comprised 356 patients who were scheduled to receive the rhPSMA-7.3 (18F) injection and met the inclusion/exclusion criteria

Complete source fields

denoms

counts
group Id
BG000
value
356
units
Participants

groups

description
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron Emission Tomography scan: imaging test with radioligand
id
BG000
title
Single Arm

measures

classes
categories
measurements
group Id
BG000
spread
6.98
value
64.9
denoms
counts
group Id
BG000
value
356
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
163
denoms
counts
group Id
BG000
value
356
units
Participants
title
< 65 years
categories
measurements
group Id
BG000
value
193
denoms
counts
group Id
BG000
value
356
units
Participants
title
≥ 65 years
description
Age in years split into 2 groups
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
0
title
Female
measurements
group Id
BG000
value
356
title
Male
denoms
counts
group Id
BG000
value
356
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
17
title
Hispanic or Latino
measurements
group Id
BG000
value
311
title
Not Hispanic or Latino
measurements
group Id
BG000
value
28
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
356
units
Participants
description
Ethnicity split into 2 substantive groups and those for whom it was not reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
30
denoms
counts
group Id
BG000
value
356
units
Participants
title
Black or African American
categories
measurements
group Id
BG000
value
289
denoms
counts
group Id
BG000
value
356
units
Participants
title
White
categories
measurements
group Id
BG000
value
4
denoms
counts
group Id
BG000
value
356
units
Participants
title
Other
categories
measurements
group Id
BG000
value
33
denoms
counts
group Id
BG000
value
356
units
Participants
title
Not Reported
description
Race split into 3 substantive categories and also those for whom it was not reported
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
14
denoms
counts
group Id
BG000
value
356
units
Participants
title
Netherlands
categories
measurements
group Id
BG000
value
238
denoms
counts
group Id
BG000
value
356
units
Participants
title
United States
categories
measurements
group Id
BG000
value
18
denoms
counts
group Id
BG000
value
356
units
Participants
title
Finland
categories
measurements
group Id
BG000
value
86
denoms
counts
group Id
BG000
value
356
units
Participants
title
Germany
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
160
denoms
counts
group Id
BG000
value
356
units
Participants
title
=7
categories
measurements
group Id
BG000
value
87
denoms
counts
group Id
BG000
value
356
units
Participants
title
=8
categories
measurements
group Id
BG000
value
97
denoms
counts
group Id
BG000
value
356
units
Participants
title
=9
categories
measurements
group Id
BG000
value
6
denoms
counts
group Id
BG000
value
356
units
Participants
title
=10
categories
measurements
group Id
BG000
value
6
denoms
counts
group Id
BG000
value
356
units
Participants
title
≤ 6
description
Gleason score (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Score 6 - The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Score 7 - Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Score 8 - Some cells look abnormal. The cancer might grow quickly or at a moderate rate Score 9 or 10 - The cells look very abnormal. The cancer is likely to grow quickly
param Type
NUMBER
title
Total Gleason Score
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
16
denoms
counts
group Id
BG000
value
356
units
Participants
title
T1
categories
measurements
group Id
BG000
value
2
denoms
counts
group Id
BG000
value
356
units
Participants
title
T1a
categories
measurements
group Id
BG000
value
127
denoms
counts
group Id
BG000
value
356
units
Participants
title
T1c
categories
measurements
group Id
BG000
value
58
denoms
counts
group Id
BG000
value
356
units
Participants
title
T2
categories
measurements
group Id
BG000
value
18
denoms
counts
group Id
BG000
value
356
units
Participants
title
T2a
categories
measurements
group Id
BG000
value
25
denoms
counts
group Id
BG000
value
356
units
Participants
title
T2b
categories
measurements
group Id
BG000
value
33
denoms
counts
group Id
BG000
value
356
units
Participants
title
T2c
categories
measurements
group Id
BG000
value
20
denoms
counts
group Id
BG000
value
356
units
Participants
title
T3
categories
measurements
group Id
BG000
value
21
denoms
counts
group Id
BG000
value
356
units
Participants
title
T3a
categories
measurements
group Id
BG000
value
12
denoms
counts
group Id
BG000
value
356
units
Participants
title
T3b
categories
measurements
group Id
BG000
value
1
denoms
counts
group Id
BG000
value
356
units
Participants
title
T3c
categories
measurements
group Id
BG000
value
2
denoms
counts
group Id
BG000
value
356
units
Participants
title
T4
description
Tumour (T) describes the size or area of the cancer T1 means the cancer is too small to be seen on a scan, or felt during an examination of the prostate T1a means that the cancer is in less than 5% of the removed tissue T1c cancers are found by biopsy, for example after a raised PSA level T2 means the cancer is completely inside the prostate gland T3a means the cancer has broken through the capsule (covering) of the prostate gland T3b means the cancer has spread into the tubes that carry semen (seminal vesicles) T4 means the cancer has spread into other body organs nearby
param Type
NUMBER
title
TNM (Tumor-Node-Metastasis) Stage T
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
6
denoms
counts
group Id
BG000
value
356
units
Participants
title
=1
categories
measurements
group Id
BG000
value
50
denoms
counts
group Id
BG000
value
356
units
Participants
title
=2
categories
measurements
group Id
BG000
value
110
denoms
counts
group Id
BG000
value
356
units
Participants
title
=3
categories
measurements
group Id
BG000
value
87
denoms
counts
group Id
BG000
value
356
units
Participants
title
=4
categories
measurements
group Id
BG000
value
103
denoms
counts
group Id
BG000
value
356
units
Participants
title
=5
description
GGG (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Group 1: The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Group 2: Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Group 3: The cells look less like normal prostate cells. The cancer is likely to grow at a moderate rate Group 4: Some cells look abnormal. The cancer might grow quickly or at a moderate rate Group 5: The cells look very abnormal. The cancer is likely to grow quickly
param Type
NUMBER
title
Gleason Grade Group (GGG)
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
290
denoms
counts
group Id
BG000
value
356
units
Participants
title
M0
categories
measurements
group Id
BG000
value
4
denoms
counts
group Id
BG000
value
356
units
Participants
title
M1
categories
measurements
group Id
BG000
value
1
denoms
counts
group Id
BG000
value
356
units
Participants
title
M1a
categories
measurements
group Id
BG000
value
1
denoms
counts
group Id
BG000
value
356
units
Participants
title
M1b
categories
measurements
group Id
BG000
value
48
denoms
counts
group Id
BG000
value
356
units
Participants
title
MX
categories
measurements
group Id
BG000
value
12
denoms
counts
group Id
BG000
value
356
units
Participants
title
Missing
description
Metastasis (M) describes whether the cancer has spread to a different part of the body. M0 means the cancer hasn't spread to other parts of your body. M1 means the cancer has spread to other parts of the body outside the pelvis. It is split into M1a, M1b and M1c. M1a means there are cancer cells in lymph nodes outside the pelvis M1b means there are cancer cells in the bone M1c means there are cancer cells in other parts of the body such as the lungs
param Type
NUMBER
title
TNM Stage M
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
2
denoms
counts
group Id
BG000
value
356
units
Participants
title
>1.0 to 2.0
categories
measurements
group Id
BG000
value
62
denoms
counts
group Id
BG000
value
356
units
Participants
title
>2.0 to 5.0
categories
measurements
group Id
BG000
value
134
denoms
counts
group Id
BG000
value
356
units
Participants
title
>5.0 to 10.0
categories
measurements
group Id
BG000
value
158
denoms
counts
group Id
BG000
value
356
units
Participants
title
>10.0
param Type
NUMBER
title
Prostate-specific antigen (PSA) Characterization (ng/mL)
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
241
denoms
counts
group Id
BG000
value
356
units
Participants
title
High-risk or Veryhigh-risk
categories
measurements
group Id
BG000
value
115
denoms
counts
group Id
BG000
value
356
units
Participants
title
Immediate-Risk
description
Baseline Risk Category. High-risk or Very-high risk defined as meeting any one of these criteria: T-stage T3 (including T3a and T3b) or T4, GGG 4 or 5, Primary Gleason pattern 5, or PSA \>20 ng/mL.
param Type
NUMBER
title
Baseline Risk Category
unit Of Measure
participants

population Description

The FAS comprised 356 patients who were scheduled to receive the rhPSMA-7.3 (18F) injection and met the inclusion/exclusion criteria

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Preserved source evidence · Not medical advice