Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Heart and Blood Diseases

Neoplasms

Nervous System Diseases

Kidney Diseases

Hypertension

Prostatic Neoplasms

Autonomic Nervous System Diseases

Primary Dysautonomias

Vascular Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Androgens

Hormones

Leuprolide

Goserelin

Bicalutamide

Flutamide

Androgen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Androgen Antagonists

Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer

Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks

Healthy men undergoing placebo for 9 weeks.

Gonadotropin-Releasing Hormone Agonist

Androgen receptor inhibitor

Placebo

Matthew Babcock, PhD

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.

Contributions to Hypertension With Androgen Deprivation Therapy

Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy

Proteomic analysis of inflammatory cascade proteins will be quantified in plasma samples.

Whole blood reactive oxygen species will be measured in from venous blood samples using electron paramagnetic resonance spectroscopy

Descriptive variable total body fat mass (for screening and to document any changes with the intervention)

The change in cardiovagal baroreflex sensitivity will be assessed the modified Oxford procedure

The change in blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test

The change in blood pressure will be assessed from quiet rest to isometric handgrip exercise

Ambulatory blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring.

Beat-to-beat blood pressure variability will be using finger photoplethysmography measured in the laboratory.

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.

Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule (KIM)-1, interleukin (IL)-18, and vanin-1 will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.

Changes in muscle sympathetic nerve activity in response to changes in blood pressure will be assessed using the modified Oxford procedure

The change in muscle sympathetic nerve activity will be assessed from quiet rest to sympathetic activation using the cold pressor test.

Glomerular filtration rate and renal plasma flow will be calculated by iohexol (Omnipaque 300, GE Healthcare) clearance technique. Plasma and urine iohexol and p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).

Renal plasma flow will be calculated by p-aminohippurate (Basic Pharma) clearance techniques. Plasma and urine p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).

University of Colorado, Denver

Symptoms and General Pathology

Rare Diseases

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Kennedy Disease

Dermatologic Agents

Coal Tar

Participants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 months.

Participants will receive apalutamide 240mg (4 x 60 mg tablets) orally once a day for up to 3 months followed by placebo to match apalutamide (4 tablets) orally once a day for up to 3 months.

Participants will receive placebo to match apalutamide (4 tablets) orally once a day for up to 6 months.

Apalutamide is a selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.

Apalutamide Oral Tablet [Erleada]

Aneta Drozd

Vincent J Gnanapragasam, Prof.

This is a phase 3, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for prostate cancer.

The trial will occur in two stages. Following an initial 3-arm Pilot stage, a go-no go decision will be made. If successful, the trial will progress and adapt to become a 2-arm trial in the subsequent stage.

TherApeutics in Early ProState Cancer (TAPS02)

Targeted Drug Intervention in Men at Risk of Progression on Active Surveillance for Early Prostate Cancer: A Randomised Trial - Therapeutics in Active Prostate Cancer Surveillance (TAPS02).

To determine whether there is a reduction in MRI defined tumour volume at 12 months post treatment in at least 50% of the treated cohort in either treatment arm compared to the baseline measurement.

To determine whether there is a 50% reduction in cumulative 3-year progression rate to ≥ Grade Group 3 or T3 stage and composite score of ≥ CPG3 disease.

Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC-QLQC30).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Contributions to Hypertension With Androgen Deprivation Therapy	NCT05700903	Androgen Depriv... Prostate Cancer Hypertension Autonomic Dysfu... Renal Disease	Gonadotropin-Re... Androgen recept... Placebo	40 Years -	University of Colorado, Denver
TherApeutics in Early ProState Cancer (TAPS02)	NCT05191680	Prostate Cancer	Apalutamide Ora... Placebo	18 Years -	Cambridge University Hospitals NHS Foundation Trust
Contributions to Hypertension With Androgen Deprivation Therapy	NCT05700903	Androgen Depriv... Prostate Cancer Hypertension Autonomic Dysfu... Renal Disease	Gonadotropin-Re... Androgen recept... Placebo	40 Years -	University of Colorado, Denver

Spots Global Cancer Trial Database for androgen receptor inhibitor