Trial Outcomes & Findings for Contributions to Hypertension With Androgen Deprivation Therapy (NCT NCT05700903)
NCT ID: NCT05700903
Last Updated: 2026-09-02
Results Overview
Neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases 2 (TIMP2), and insulin-like growth factor binding protein 7 (IGFBP7) will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.
TERMINATED
PHASE4
10 participants
Before and after 9 weeks of androgen deprivation therapy or placebo
2026-09-02
Participant Flow
Participants were recruited from the Denver Metro area between September 2023 and June 2025. The first participant was enrolled on September 20, 2023 and the last participant was enrolled in April 2025.
A total of 277 men expressed interest in participating in the study. Of these, 234 were determined ineligible or were not interested after receiving a description of the study and 43 reported for consent and screening. Thirty three were not eligible and 10 were enrolled into the study.
Participant milestones
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
Healthy men undergoing placebo for 9 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
4
|
6
|
|
Overall Study
COMPLETED
|
0
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contributions to Hypertension With Androgen Deprivation Therapy
Baseline characteristics by cohort
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
n=4 Participants
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
n=6 Participants
Healthy men undergoing placebo for 9 weeks.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=136 Participants
|
4 Participants
n=136 Participants
|
6 Participants
n=272 Participants
|
10 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=136 Participants
|
4 Participants
n=136 Participants
|
6 Participants
n=272 Participants
|
10 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
7 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
2 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
8 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Body Mass Index
|
—
|
25.8 kg/m2
STANDARD_DEVIATION 2.8 • n=136 Participants
|
25.8 kg/m2
STANDARD_DEVIATION 2.6 • n=272 Participants
|
25.8 kg/m2
STANDARD_DEVIATION 2.7 • n=60 Participants
|
|
Systolic Blood Pressure
|
—
|
126 mmHg
STANDARD_DEVIATION 7 • n=136 Participants
|
123 mmHg
STANDARD_DEVIATION 9 • n=272 Participants
|
125 mmHg
STANDARD_DEVIATION 8 • n=60 Participants
|
|
Diastolic Blood Pressure
|
—
|
80 mmHg
STANDARD_DEVIATION 4 • n=136 Participants
|
80 mmHg
STANDARD_DEVIATION 4 • n=272 Participants
|
80 mmHg
STANDARD_DEVIATION 4 • n=60 Participants
|
|
Total Testosterone
|
—
|
421 ng/dL
STANDARD_DEVIATION 30 • n=136 Participants
|
537 ng/dL
STANDARD_DEVIATION 174 • n=272 Participants
|
491 ng/dL
STANDARD_DEVIATION 144 • n=60 Participants
|
PRIMARY outcome
Timeframe: Before and after 9 weeks of androgen deprivation therapy or placeboPopulation: No participants were enrolled in the Prostate Cancer arm; therefore, no data were available for analysis for this group.
The change in cardiovagal baroreflex sensitivity will be assessed via the sequence method
Outcome measures
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
n=4 Participants
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
n=6 Participants
Healthy men undergoing placebo for 9 weeks.
|
|---|---|---|---|
|
Change in Cardiovagal Baroreflex Sensitivity
|
—
|
-4.82 ms/mmHg
Standard Deviation 1.84
|
0.56 ms/mmHg
Standard Deviation 1.48
|
PRIMARY outcome
Timeframe: Before and after 9 weeks of androgen deprivation therapy or placeboPopulation: No participants were enrolled in the Prostate Cancer arm; therefore, no data were available for analysis for this group.
The change in systolic blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test
Outcome measures
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
n=4 Participants
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
n=6 Participants
Healthy men undergoing placebo for 9 weeks.
|
|---|---|---|---|
|
Change in Blood Pressure Reactivity to the Cold Pressor Test
|
—
|
9.6 mmHg
Standard Deviation 4.0
|
2.2 mmHg
Standard Deviation 5.6
|
PRIMARY outcome
Timeframe: Before and after 9 weeks of androgen deprivation therapy or placeboPopulation: No participants were enrolled in the Prostate Cancer arm; therefore, no data were available for analysis for this group.
The change in systolic blood pressure will be assessed from quiet rest to isometric handgrip exercise
Outcome measures
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
n=4 Participants
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
n=6 Participants
Healthy men undergoing placebo for 9 weeks.
|
|---|---|---|---|
|
Change in Exercise Pressor Reflex
|
—
|
6.0 mmHg
Standard Deviation 2.1
|
0.8 mmHg
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Before and after 9 weeks of androgen deprivation therapy or placeboPopulation: No participants were enrolled in the Prostate Cancer arm; therefore, no data were available for analysis for this group.
Ambulatory systolic blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring using the standard deviation of blood pressure readings
Outcome measures
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
n=4 Participants
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
n=6 Participants
Healthy men undergoing placebo for 9 weeks.
|
|---|---|---|---|
|
Change in Ambulatory Blood Pressure Variability
|
—
|
4.1 mmHg
Standard Deviation 2.2
|
-1.6 mmHg
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: Before and after 9 weeks of androgen deprivation therapy or placeboPopulation: No participants were enrolled in the Prostate Cancer arm; therefore, no data were available for analysis for this group.
Beat-to-beat systolic blood pressure variability will be determined using the standard deviation of blood pressure readings from finger photoplethysmography measured in the laboratory.
Outcome measures
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
n=4 Participants
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
n=6 Participants
Healthy men undergoing placebo for 9 weeks.
|
|---|---|---|---|
|
Change in Beat-to-beat Blood Pressure Variability
|
—
|
6.2 mmHg
Standard Deviation 1.8
|
0.4 mmHg
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Before and after 9 weeks of androgen deprivation therapy or placeboPopulation: No participants were enrolled in the Prostate Cancer arm; therefore, no data were available for analysis for this group.
Renal blood flow will be determined using ultrasound and blood pressure will be determined using finger photoplethysmography. These measures will be used to estimate renal vascular resistance.
Outcome measures
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
n=4 Participants
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
n=6 Participants
Healthy men undergoing placebo for 9 weeks.
|
|---|---|---|---|
|
Change in Renal Vascular Resistance
|
—
|
1.14 mmHg/cm/s
Standard Deviation 0.26
|
0.81 mmHg/cm/s
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: Before and after 9 weeks of androgen deprivation therapy or placeboPopulation: No participants were enrolled in the Prostate Cancer arm; therefore, no data were available for analysis for this group.
Neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases 2 (TIMP2), and insulin-like growth factor binding protein 7 (IGFBP7) will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.
Outcome measures
| Measure |
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
|
Healthy + ADT
n=4 Participants
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
|
Healthy + Placebo
n=6 Participants
Healthy men undergoing placebo for 9 weeks.
|
|---|---|---|---|
|
Change in Renal Dysfunction Biomarkers
TIMP2
|
—
|
0.33 ng/min
Standard Deviation 0.33
|
-0.32 ng/min
Standard Deviation 0.28
|
|
Change in Renal Dysfunction Biomarkers
IGFBP7
|
—
|
33.89 ng/min
Standard Deviation 26.23
|
-3.75 ng/min
Standard Deviation 8.31
|
Adverse Events
Prostate Cancer
Healthy + ADT
Healthy + Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place