Primary outcomeMean· Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Cardiovagal Baroreflex Sensitivity
| Group | Value (ms/mmHg) | Spread |
|---|---|---|
| Prostate Cancer | not posted | – |
| Healthy + ADT | -4.82 | 1.84 |
| Healthy + Placebo | 0.56 | 1.48 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataContributions to Hypertension With Androgen Deprivation Therapy
Short name ARCH
NCTNCT05700903 (opens ClinicalTrials.gov in a new tab)Other id22-2201.cc
This trial was stopped early.
Reason given at the registry: Study completed
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 10 participants (actual)
- Sponsor
- University of Colorado, Denver · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 20 Sept 2023
- Primary completion
- 16 Jul 2025
- Completion
- 16 Jul 2025
- First posted
- 26 Jan 2023
- Last update posted
- 2 Sept 2026
- Conditions
- Androgen Deprivation Therapy · Prostate Cancer · Hypertension · Autonomic Dysfunction · Renal Disease
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2023202420252026
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.
Interventions
- Gonadotropin Releasing Hormone Agonists (GNRH)Drug
- Androgen receptor (AR) inhibitorDrug
- PlaceboDrug
Arms3
Active comparator
Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
Active comparator
Healthy + ADT
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
Placebo comparator
Healthy + Placebo
Healthy men undergoing placebo for 9 weeks.
Primary outcomes7
Outcomes the sponsor listed as primary.
Change in Cardiovagal Baroreflex Sensitivity
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Registry description
The change in cardiovagal baroreflex sensitivity will be assessed via the sequence method
Change in Blood Pressure Reactivity to the Cold Pressor Test
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Registry description
The change in systolic blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test
Change in Exercise Pressor Reflex
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Registry description
The change in systolic blood pressure will be assessed from quiet rest to isometric handgrip exercise
Change in Ambulatory Blood Pressure Variability
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Registry description
Ambulatory systolic blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring using the standard deviation of blood pressure readings
Change in Beat-to-beat Blood Pressure Variability
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Registry description
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.
Change in Renal Vascular Resistance
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Registry description
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.
Change in Renal Dysfunction Biomarkers
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Blood Pressure Reactivity to the Cold Pressor Test
| Group | Value (mmHg) | Spread |
|---|---|---|
| Prostate Cancer | not posted | – |
| Healthy + ADT | 9.6 | 4.0 |
| Healthy + Placebo | 2.2 | 5.6 |
Primary outcomeMean· Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Exercise Pressor Reflex
| Group | Value (mmHg) | Spread |
|---|---|---|
| Prostate Cancer | not posted | – |
| Healthy + ADT | 6.0 | 2.1 |
| Healthy + Placebo | 0.8 | 1.4 |
Primary outcomeMean· Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Ambulatory Blood Pressure Variability
| Group | Value (mmHg) | Spread |
|---|---|---|
| Prostate Cancer | not posted | – |
| Healthy + ADT | 4.1 | 2.2 |
| Healthy + Placebo | -1.6 | 3.1 |
Primary outcomeMean· Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Beat-to-beat Blood Pressure Variability
| Group | Value (mmHg) | Spread |
|---|---|---|
| Prostate Cancer | not posted | – |
| Healthy + ADT | 6.2 | 1.8 |
| Healthy + Placebo | 0.4 | 2.2 |
Primary outcomeMean· Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Renal Vascular Resistance
| Group | Value (mmHg/cm/s) | Spread |
|---|---|---|
| Prostate Cancer | not posted | – |
| Healthy + ADT | 1.14 | 0.26 |
| Healthy + Placebo | 0.81 | 0.14 |
Primary outcomeMean· Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Renal Dysfunction Biomarkers
| Group | Value (ng/min) | Spread |
|---|---|---|
| Prostate Cancer | not posted | – |
| Healthy + ADT | 0.33 | 0.33 |
| Healthy + Placebo | -0.32 | 0.28 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Prostate CancerMen undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer | 0 / 0 | 0 / 0 | 0 / 0 |
| Healthy + ADTHealthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks | 0 / 4 | 0 / 4 | 0 / 4 |
| Healthy + PlaceboHealthy men undergoing placebo for 9 weeks. | 0 / 6 | 0 / 6 | 0 / 6 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 40 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* -age 40+ years;
* resting blood pressure \<140/90 mmHg;
* fasted blood glucose \<126 mg/dL;
* testosterone ≥400 ng/dL;
* sedentary to recreationally active;
* nonsmokers;
* healthy as determined by medical history, physical exam, blood and urine chemistries and resting and exercise ECG during a physician supervised graded exercise treadmill test OR recent diagnosis of non-metastatic prostate cancer with plans to undergo androgen deprivation therapy;
* PSA \<4.00 ng/dL if in the non-cancer group;
* Gleason Score ≤7 if in the prostate cancer group;
* no use of medications that might influence cardiovascular function (e.g., antihypertensives, lipid-lowering medications);
* willing and able to be on GnRHagonist and AR inhibitor;
* not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications, or willing to stop use for four weeks prior to the start of the study;
* not using exogenous sex hormones for at least one year
Exclusion Criteria:
* -acute liver disease;
* chronic kidney disease, serum creatinine \>1.3 mg/dL, macroalbuminuria \>300 mg/g of proteinuria
* pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizure disorder;
* diabetes, active or chronic infection, disease that affects the nervous system;
* Gleason Score ≥8;
* thyroid dysfunction, defined as ultrasensitive TSH \<0.5 or \>5.0 mU/L, volunteers with abnormal TSH values will be re-considered for participation after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
* tobacco use within the previous 12 months
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