40 and older, male only, with Prostate Adenocarcinoma or Stage I Prostate Cancer AJCC V7. 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.
Change From Baseline in Fasting Glucose at 6 MonthsPrimary· Baseline to 6 months
Mean and standard deviation of change from baseline.
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
-3.65
± 21
Arm II (Control)
4.5
± 47
Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 MonthsPrimary· Baseline to 6 months
Mean and standard deviation of change from baseline.
C-peptide (ng/mL)
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
-0.55
± 0.72
Arm II (Control)
0.06
± 0.65
IGF-BP3 (ng/mL)
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
-363
± 818
Arm II (Control)
-297
± 881
IGF-1 (ng/mL)
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
6.2
± 54
Arm II (Control)
-4.7
± 51
Adiponectin (ng/mL)
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
696
± 3124
Arm II (Control)
4.2
± 1652
Weight at 12 MonthsPrimary· 12 months (6 months after active intervention)
Mean and standard deviation of weight at 12 months
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
90.0
± 14.3
Arm II (Control)
99.2
± 20.1
Change From Baseline in Fasting Insulin at 6 MonthsPrimary· Baseline to 6 months
Mean and standard deviation of change from baseline.
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
-2.3
± 4.9
Arm II (Control)
-0.19
± 4.6
Health Related Quality of Life (HRQOL) at 6 MonthsSecondary· 6 months
Mean and standard deviation of Quality of Life measures at 6 months.
Overall Anxiety (MAX-PC); range 0-54, higher score indicates more anxiety
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
16.9
± 7.5
Arm II (Control)
16.6
± 6.3
Urinary Quality of Life (EPIC-26); range 0-100, higher score indicates better urinary QOL
Group
Value
95% CI
Arm I (Diet and Exercise Lifestyle Intervention)
88.1
± 11.6
Arm II (Control)
82.9
± 12.7
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized phase III trial studies a diet and exercise program based on the Diabetes Prevention Program to promote weight loss and improve health in men with low-risk or low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that promotes weight loss may influence prostate health. A combined diet and exercise program that is based on the Diabetes Prevention Program may affect markers (or "biomarkers") of prostate cancer progression. Gathering this information may help doctors understand how obesity affects prostate cancer progression and may help lead to a program that can reduce the risk of prostate cancer progression.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06733363 — A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscl
· Phase 2
· recruiting
NCT06643455 — Mindfulness Intervention for Improving Nutrition in the Digital Kitchen Among Stage I-III Breast Cancer Survivors, MIND
· NA
· active not recruiting
NCT06315296 — An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Surviva
· NA
· terminated
NCT06030427 — Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors
· NA
· completed
NCT04548193 — Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
Last refreshed: 4 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02454517.