Trial Outcomes & Findings for Effect of Weight Loss on Prostate Cancer Pathology (NCT NCT00475982)
NCT ID: NCT00475982
Last Updated: 2019-01-31
Results Overview
The primary objective is to compare the mean apoptotic index in the radical prostatectomy malignant epithelium between the Weight Loss Group and the Control Group-No Weight Loss. The apoptotic index will be measured in the malignant epithelium with the highest Gleason grade. TUNEL staining was used to identify these apoptotic cells and measure the apoptotic index, which is the percent of cells stained from the sample.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-01-31
Participant Flow
Participant milestones
| Measure |
Arm 1: Weight Loss
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Arm 1: Weight Loss
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Overall Study
surgery rescheduled
|
7
|
3
|
Baseline Characteristics
Effect of Weight Loss on Prostate Cancer Pathology
Baseline characteristics by cohort
| Measure |
Arm 1: Weight Loss
n=16 Participants
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
n=18 Participants
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThe primary objective is to compare the mean apoptotic index in the radical prostatectomy malignant epithelium between the Weight Loss Group and the Control Group-No Weight Loss. The apoptotic index will be measured in the malignant epithelium with the highest Gleason grade. TUNEL staining was used to identify these apoptotic cells and measure the apoptotic index, which is the percent of cells stained from the sample.
Outcome measures
| Measure |
Arm 1: Weight Loss
n=16 Participants
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
n=18 Participants
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention
|
6.9 percentage of cells stained
Standard Deviation 10.4
|
5.0 percentage of cells stained
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 8 weeksThe proliferative index in prostate cancer epithelium obtained from the radical prostatectomy specimen. This index was procured by staining the Ki67 protein to measure cell proliferation. (Note: Ki67 is a common indicator of cell proliferation.)
Outcome measures
| Measure |
Arm 1: Weight Loss
n=16 Participants
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
n=18 Participants
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Proliferative Index in Prostate Cancer Epithelium Specimen
|
6.69 percentage of cells stained
Standard Deviation 5.05
|
5.79 percentage of cells stained
Standard Deviation 3
|
SECONDARY outcome
Timeframe: baseline and post-interventionThis outcome is the measure of the hormone insulin-like growth factor 1 at baseline vs. post-intervention. We measured and compared the concentration (ng/mL) of this hormone.
Outcome measures
| Measure |
Arm 1: Weight Loss
n=16 Participants
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
n=18 Participants
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Change in Serum IGF-related Analytes: IGF-1
Pre
|
165.8 ng/mL
Standard Deviation 43.1
|
127.9 ng/mL
Standard Deviation 50.7
|
|
Change in Serum IGF-related Analytes: IGF-1
Post
|
171.2 ng/mL
Standard Deviation 53.4
|
124.8 ng/mL
Standard Deviation 53.1
|
|
Change in Serum IGF-related Analytes: IGF-1
Change
|
5.38 ng/mL
Standard Deviation 19.8
|
-3.12 ng/mL
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: baseline and post-interventionThis outcome is the measure of the protein, insulin-like growth factor binding protein 1, at baseline vs. post-intervention. We measured and compared the concentration (ng/mL) of this protein.
Outcome measures
| Measure |
Arm 1: Weight Loss
n=16 Participants
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
n=18 Participants
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Change in Serum IGF-related Analytes: IGFBP-1
Pre
|
8.78 ng/mL
Standard Deviation 5.87
|
16.7 ng/mL
Standard Deviation 11.1
|
|
Change in Serum IGF-related Analytes: IGFBP-1
Post
|
10.9 ng/mL
Standard Deviation 5.77
|
16.6 ng/mL
Standard Deviation 11.2
|
|
Change in Serum IGF-related Analytes: IGFBP-1
Change
|
2.19 ng/mL
Standard Deviation 5.95
|
-0.03 ng/mL
Standard Deviation 7.43
|
SECONDARY outcome
Timeframe: baseline and post-interventionThe BRDU assay measures proliferation of cultured cells such as LNCaP. We expose the cells to the patient blood and see if it inhibits prostate cancer cell growth ex vivo. We use optical density (a measure of the amount of light able to pass through the specimen) to indicate the concentration of cell proliferation.
Outcome measures
| Measure |
Arm 1: Weight Loss
n=16 Participants
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
n=18 Participants
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells
Pre
|
92.8 density units
Standard Deviation 25.8
|
84.8 density units
Standard Deviation 27.3
|
|
Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells
Post
|
90.8 density units
Standard Deviation 23.4
|
83.5 density units
Standard Deviation 26.9
|
|
Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells
Change
|
-2.01 density units
Standard Deviation 7.23
|
-1.24 density units
Standard Deviation 12.72
|
SECONDARY outcome
Timeframe: baseline and post-interventionThis change in body weight is observed by DEXA, a scanner that measures total body composition.
Outcome measures
| Measure |
Arm 1: Weight Loss
n=16 Participants
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
n=18 Participants
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Change in Body Weight
Pre
|
102.19 kg
Standard Deviation 17.15
|
101.02 kg
Standard Deviation 17.55
|
|
Change in Body Weight
Post
|
98.47 kg
Standard Deviation 16.78
|
99.38 kg
Standard Deviation 16.42
|
|
Change in Body Weight
Change
|
-3.71 kg
Standard Deviation 1.85
|
-1.60 kg
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: baseline and post-interventionThis change in percent body fat is observed by DEXA, a scanner that measures total body composition.
Outcome measures
| Measure |
Arm 1: Weight Loss
n=16 Participants
Weight Loss Group
Weight Loss: Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
|
Arm 2: No Weight Loss
n=18 Participants
No Weight Loss Group
No Weight Loss Group: These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.
|
|---|---|---|
|
Change in Percent Body Fat
Post
|
35.9 percentage of body fat
Standard Deviation 4.8
|
36.9 percentage of body fat
Standard Deviation 5.4
|
|
Change in Percent Body Fat
Change
|
-0.93 percentage of body fat
Standard Deviation 1.92
|
0.41 percentage of body fat
Standard Deviation 0.9
|
|
Change in Percent Body Fat
Pre
|
36.8 percentage of body fat
Standard Deviation 3.7
|
36.5 percentage of body fat
Standard Deviation 4.7
|
Adverse Events
Arm 1: Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: No Weight Loss
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
William Aronson, MD
VA Medical Center Greater Los Angeles Healthcare System
Phone: 3102683446
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place