N/A
Completed N=20
Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
Localized Prostate Carcinoma · Prostate adenocarcinoma
Source: ClinicalTrials.gov NCT04870515 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) — 4.5; 42.7 percentage change
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
4.5; 42.7 | — |
| PRIMARY Effects of the Intervention on ADT-induced Changes in Body Weight |
-1.24; 1.01 | — |
| PRIMARY Effects of the Intervention on ADT-induced Changes in Waist Circumference |
3.4; 1.8 | — |
| PRIMARY Effects of the Intervention on ADT-induced Changes in Lean Mass |
-998; -1129 | — |
| PRIMARY Effects of the Intervention on ADT-induced Changes in Fat Mass |
1307; 2491 | — |
Eligibility Criteria
Inclusion Criteria
- Age >= 40 years
- Histologically confirmed adenocarcinoma of the prostate, (D'Amico risk category intermediate or high risk, localized or locoregional)
- Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directed therapies] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed
- Physically able to undertake an exercise program
Exclusion Criteria
- Advanced, metastatic disease
- Planning to join a commercial/structured diet change or fitness program
- Have significant pre-existing T2D (poor glycemic control while on medication, defined as hemoglobin A1c of >= 10 within the prior 12 months) or significant pre-existing cardiovascular disease (CVD) (myocardial infarction or stroke within prior six months)
- Physician confirmed cognitive impairment or alcohol/narcotic abuse
Data sourced from ClinicalTrials.gov (NCT04870515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.