NCT04870515

Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study

Completed NA Results posted Last updated 9 January 2026

What this trial tests

NA trial testing Best Practice in Localized Prostate Carcinoma in 20 participants. Completed in 18 December 2024.

Timeline

4 November 2021

Primary endpoint
18 December 2024

18 December 2024

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	20
Start date	4 November 2021
Primary completion	18 December 2024
Estimated completion	18 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Best Practice
• Dietary Intervention
• Exercise Intervention
• Quality-of-Life Assessment
• Questionnaire Administration

Conditions studied

• Localized Prostate Carcinoma — all drugs for Localized Prostate Carcinoma →
• Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

40 and older, male only, with Localized Prostate Carcinoma or Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Primary · 0 months, 6 months

Data is reported as a percentage change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score from baseline. HOMA-IR is an index to estimate the insulin resistance of a patient. HOMA-IR is defined as (glucose (mg/dl) insulin (uIU/ml)) / 405.

Group	Value	95% CI
Group I (Diet, Physical Activity)	4.5	± 52.1
Group II (Standard Lifestyle Recommendations)	42.7	± 28.1

Effects of the Intervention on ADT-induced Changes in Body Weight Primary · 0 months, 6 months

Change in body weight from baseline.

Group	Value	95% CI
Group I (Diet, Physical Activity)	-1.24	± 2.6
Group II (Standard Lifestyle Recommendations)	1.01	± 1.9

Effects of the Intervention on ADT-induced Changes in Waist Circumference Primary · 0 months, 6 months

Change in waist circumference from baseline. Waist circumference was measured at 1" above umbilicus.

Group	Value	95% CI
Group I (Diet, Physical Activity)	3.4	± 1.5
Group II (Standard Lifestyle Recommendations)	1.8	± 7.3

Effects of the Intervention on ADT-induced Changes in Lean Mass Primary · 0 months, 6 months

Change in lean mass from baseline. Lean mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).

Group	Value	95% CI
Group I (Diet, Physical Activity)	-998	± 1604
Group II (Standard Lifestyle Recommendations)	-1129	± 1423

Effects of the Intervention on ADT-induced Changes in Fat Mass Primary · 0 months, 6 months

Change in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).

Group	Value	95% CI
Group I (Diet, Physical Activity)	1307	± 2984
Group II (Standard Lifestyle Recommendations)	2491	± 1189

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group I (Diet, Physical Activity)

Serious: 0/9 (0%)

Deaths: 0/9

Group II (Standard Lifestyle Recommendations)

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (6 terms — click to expand)

Reaction	System	Group I (Diet, Physical Ac…	Group II (Standard Lifesty…
Knee Pain	Musculoskeletal and connective tissue disorders	—	—
Fatigue	General disorders	—	—
Hip and back pain	Musculoskeletal and connective tissue disorders	—	—
elevated liver function tests	Hepatobiliary disorders	—	—
Urinary retention	Renal and urinary disorders	—	—
Presyncope	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT04870515 adverse events section.

Sponsor's own description

This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (RT) and androgen deprivation therapy (ADT). ADT effectively slows the growth of prostate cancer cells, thereby enhancing the therapeutic effectiveness of RT. Despite the clinical gains, ADT leads to an array of side effects including insulin resistance, abnormal lipid levels, weight gain, increased visceral fat mass coupled with increased muscle wasting, and quality of life deterioration. A diet and physical activity intervention may intercept or prevent the abrupt metabolic and physiologic changes caused by androgen deprivation therapy in prostate cancer patients receiving ADT and RT.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Myosteatosis and Sarcopenic Obesity in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: Rationale for Mechanism-Driven Multimodal Intervention.
   Kumar NB, Parker N, Zhang J, Pow-Sang J, et al · · 2026 · PMID 42073599 · DOI 10.3390/cancers18081276