Androgen Deprivation TherapyPhase 4ARCHNCT05700903
Contributions to Hypertension With Androgen Deprivation Therapy
A Phase 4 study testing Gonadotropin Releasing Hormone Agonists (GNRH) and Androgen receptor (AR) inhibitor in people with Androgen Deprivation Therapy and Prostate Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgen Deprivation Therapy, Prostate Cancer, Hypertension
- What is being tested?
- Gonadotropin Releasing Hormone Agonists (GNRH) and Androgen receptor (AR) inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 16 Jul 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -age 40+ years;
- resting blood pressure <140/90 mmHg;
- fasted blood glucose <126 mg/dL;
- testosterone ≥400 ng/dL;
- sedentary to recreationally active;
- nonsmokers;
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- 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
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy
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.
- Conditions
- Androgen Deprivation Therapy, Prostate Cancer, Hypertension, Autonomic Dysfunction, Renal Disease
- Being tested
- Gonadotropin Releasing Hormone Agonists (GNRH), Androgen receptor (AR) inhibitor, Placebo
- Medical subject headings
- Prostatic Neoplasms, Hypertension, Primary Dysautonomias, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin Releasing Hormone Agonists (GNRH)Drug
Also called Leuprolide, Goserelin
8 weeks of GnRH agonist
Androgen receptor (AR) inhibitorDrug
Also called Bicalutamide, Flutamide, Enzalutamide
2 weeks of AR Inhibitor
PlaceboDrug
Placebo tablet and injection
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Active comparator | Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer Receives: Drug: Gonadotropin Releasing Hormone Agonists (GNRH); Drug: Androgen receptor (AR) inhibitor |
| Healthy + ADT | Active comparator | Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks Receives: Drug: Gonadotropin Releasing Hormone Agonists (GNRH); Drug: Androgen receptor (AR) inhibitor |
| Healthy + Placebo | Placebo comparator | Healthy men undergoing placebo for 9 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiovagal Baroreflex Sensitivity
The change in cardiovagal baroreflex sensitivity will be assessed via the sequence method
Measured: Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Blood Pressure Reactivity to the Cold Pressor Test
The change in systolic blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test
Measured: Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Exercise Pressor Reflex
The change in systolic blood pressure will be assessed from quiet rest to isometric handgrip exercise
Measured: Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Ambulatory Blood Pressure Variability
Ambulatory systolic blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring using the standard deviation of blood pressure readings
Measured: Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Beat-to-beat Blood Pressure Variability
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.
Measured: Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Renal Vascular Resistance
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.
Measured: Before and after 9 weeks of androgen deprivation therapy or placebo
Change in Renal Dysfunction Biomarkers
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.
Measured: Before and after 9 weeks of androgen deprivation therapy or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start20 Sep 2023
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Why it stopped: Study completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Androgen Deprivation TherapyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Babcock, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700903
- Sponsor's protocol ID
- 22-2201.cc
- Acronym
- ARCH
- Status last verified
- Aug 2026
- First submitted
- 10 Jan 2023
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No