diet and prostate cancer: now what?€¦ · clinical trial of a diet intervention in men on active...

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Diet and Prostate Cancer: Now What? J. Kellogg Parsons, MD, MHS, FACS Professor and Endowed Chair Department of Urology UC San Diego

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Page 1: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Diet and Prostate Cancer: Now What?J. Kellogg Parsons, MD, MHS, FACSProfessor and Endowed Chair Department of UrologyUC San Diego

Page 2: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,
Page 3: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Clinical trials are long and winding roads…

Page 4: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

J. Kellogg Parsons, David Zarieh, John P. Pierce, James Mohler, Electra

Paskett, Donna Hansel, Adam Kibel, Olwen Hahn, John Taylor, Lannis

Hall, Sean Stroup, Eric Small, Peter Van Veldhuizen, Michael J. Morris,

and James Marshall

The Men’s Eating and Living (MEAL) Study (CALGB 70807 [Alliance]): A Randomized

Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer

Support: UG1CA189823, U10CA037447, U10CA011789, U10CA041287, U10CA059518, U10CA077651, U10CA077658, U10CA138561, U10CA180791, U10CA180850, U10CA180866, U10CA180888, National Cancer Institute 1R01 CA132951-01A1,

Department of Defense PC073412, and The Prostate Cancer Foundation. ClinicalTrials.gov Identifier: NCT01238172

Plenary Session: American Urological Association Annual MeetingMay 2018

Page 5: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

MEAL is Translational Medicine

Phase II Phase III

PopulationStudies

LaboratoryStudies

Pre-surgeryStudies

Page 6: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Counseling Call Center

UC San Diego

Patient

Patient

PatientPatient

Patient

Grounded in social psychology

Promotes self-efficacy: capacity to execute behaviors to produce

specific performance attainments*

*American Psychological Association

Goal: ≥ 7 servings/ day of vegetables.

Emphasis on raw carotenoids (tomatoes and carrots).

MEAL is not:

Complementary medicine.

Wellness.

MEAL is:

Scientifically-designed, validated behavior change.

MEAL is:

Cheap.

Efficient.

Scalable to large populations.

Removes economic and practical burdens from patients.

Page 7: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

2011 to 2015n = 443

91 sites (academic & community)

Groups comparable at baseline

12% African American

< 2% Gleason 3+4=7

Page 8: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Primary endpoint: clinical progression

PSA > 10 ng/mL

or

PSADT < 3 years

or

Pathologic progression

Page 9: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

0123456

Baseline 12 months 24 months

MEALPCF

Total VegetablesServings/Day

p < 0.001

Page 10: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

0.02.04.06.08.0

10.012.0

Baseline 12 months 24 months

MEALPCF

Lycopene(Intake/day)

p < 0.001

Page 11: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

3333.5

3434.5

3535.5

36

Baseline 12 months 24 months

MEALPCF

Fat Calories (kcal/day)

p = 0.02

Page 12: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

1.2

1.4

1.6

1.8

2

2.2

Baseline 12 months

MEALPCF

Blood Carotenoids

p < 0.01

Page 13: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

PRIMARY OUTCOMES

Page 14: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Primary Endpoint: Time to Progression

HR 0.96 (95% CI: 0.75, 1.24)

p = 0.76

Page 15: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Secondary endpoint:Pathologic progression

HR 1.39 (95% CI: 0.79, 2.45)

p = 0.24

Page 16: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Take Home Messages

• Large-scale behavior change for prostate cancer is feasible.

• No significant effect on shorter term clinical progression.

• Longer term effects unclear.

Page 17: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Now What?• Quality of Life outcomes.

• Not significant in MEAL!

• Other populations.• Metastatic disease.

• Other interventions.• Exercise.

Page 18: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,
Page 19: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,
Page 20: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Take home messages• Vitamins will not prevent prostate cancer.

• No evidence that diet will alter prostate cancer.

• Telling patients to eat a healthy diet is OK……BUT saying it will treat prostate cancer is not.

Page 21: Diet and Prostate Cancer: Now What?€¦ · Clinical Trial of a Diet Intervention in Men on Active Surveillance for Prostate Cancer Support : UG1CA189823, U10CA037447, U10CA011789,

Questions?@drkellyparsons