Phase 3
N=478
Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01238172 ↗Enrolled (actual)
478
Serious AEs
—
Results posted
Mar 2019
Primary outcome: Primary: Time to Progression — 683.0; 549.0 days — p=0.76
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- dietary education and counseling (Other); prostate cancer foundation booklet (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
683.0; 549.0 | 0.76 |
| SECONDARY Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed |
3; 2 | 0.71 |
| SECONDARY Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24 |
2.0; 2.8 | 0.995 |
| SECONDARY Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall |
2.01; 0.37 | <0.001 sig |
Summary
RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
Eligibility Criteria
Preregistration Eligibility:
- Histologic Documentation:
- The initial biopsy showing diagnosis of prostate cancer should be used for the purposes of determining eligibility.
- However, if a subsequent biopsy performed before patient enrollment shows that the patient is ineligible, he may not be enrolled to the study.
- Eligible patients must meet all of the following criteria:
- Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration
- 70 years, biopsy Gleason score ≤ (3 + 4) = 7.
- Required Initial Laboratory Values:
- Serum PSA < 10 ng/mL
- NOTE: Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors.
Registration Eligibility:
- Successful completion of three 24-hour dietary recalls during the run-in period.
- Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls are not eligible.
Data sourced from ClinicalTrials.gov (NCT01238172). 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.