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Impact of Web-Based Lifestyle Interventions on Prostate Cancer Prognosis

Award Number: R01CA207749
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2016
PERIOD OF PERFORMANCE END DATE: 07/31/2024

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Impact of Web-Based Lifestyle Interventions on Prostate Cancer Prognosis - PROJECT SUMMARY Prostate cancer is the most commonly diagnosed cancer among men in the United States (US), with more than 220,800 new diagnoses expected in 2015. While a large proportion of new cases appear to have clinically indolent tumors, prostate cancer remains the second-leading cause of cancer death among men in the US. Preventing progression of initially localized prostate cancers to lethal disease is a key priority. Evidence from our group and others suggests that lifestyle factors after prostate cancer diagnosis may prevent non-metastatic prostate cancer from becoming lethal disease. We recently developed an 11-factor score based on lifestyle practices after diagnosis that is strongly associated with reduced risk of prostate cancer death (unpublished). Men with 4-7 and 8-11 points (vs. 0-3) had a 48% (HR= 0.52, 95%CI=0.32, 0.84) and 75% (HR=0.25; 95% CI=0.09, 0.69) lower risk of prostate cancer death, respectively. Based on these compelling data, we developed a lifestyle program delivered via the Internet for prostate cancer patients, with the ultimate goal of improving clinical outcomes in men with prostate cancer by incorporating a lifestyle intervention as adjuvant therapy to standard prostate cancer management. In this proposal, we aim to address the critical question – does access to an Internet-based lifestyle program (designed to increase exercise +/- improve diet quality) impact prostate biology and reduce risk of prostate cancer progression? We propose to conduct a 2-year 3-arm (web-based intervention targeting exercise vs. web-based intervention targeting exercise + diet vs. usual care) randomized controlled trial among 150 prostate cancer patients opting for surgery at the University of California, San Francisco. Men will be enrolled eight weeks before radical prostatectomy and complete follow-up assessments 6 months, 1 year, and 2 years post-surgery. Men assigned to the intervention arms will receive a two-year web- based lifestyle program post-surgery and text messaging tailored to the intervention (i.e., exercise or exercise + diet) and Fitbits. We will examine the effect of exercise vs. exercise + diet vs. usual care on: 1) a validated, FDA- approved prognostic score, Decipher, measured in biopsy (pre-intervention) and prostatectomy (post-initial 8- week intervention period) tissue; 2) mRNA expression of cancer-related pathways in tumor and normal tissue from biopsy and prostatectomy; 3) detectable PSA post-surgery and risk of prostate cancer recurrence at 2- years after radical prostatectomy; and 4) sexual and urinary function at 6 months, 1 year, and 2 years post- surgery. This study will provide critical translational data on the effect of a sustainable Internet-based intervention on prostate tumor biology and clinical outcomes in men with prostate cancer. These data will support the use of lifestyle interventions as adjuvant therapy for prostate cancer. Strengths of this proposal include our novel, evidence-based, intervention; highly relevant preliminary data; innovative prognostic biomarker outcome; and experienced multi-disciplinary team with outstanding track record.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	6	12/3/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	6	12/6/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $639,462 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	6	7/26/2021	NON-COMPETING CONTINUATION	$639,462
														Subtotal = $639,462

Issue Date FY: 2020 ( Subtotal = $1 )
2020	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	5	7/29/2020	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2019 ( Subtotal = $643,525 )
2019	2019	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	4	7/22/2019	NON-COMPETING CONTINUATION	$643,525
														Subtotal = $643,525

Issue Date FY: 2018 ( Subtotal = $672,016 )
2018	2018	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 420	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	3	7/20/2018	NON-COMPETING CONTINUATION	$672,016
														Subtotal = $672,016

Issue Date FY: 2017 ( Subtotal = $672,441 )
2017	2017	UNIVERSITY OF CALIFORNIA, SAN FRANCISCO	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	2	7/26/2017	NON-COMPETING CONTINUATION	$672,441
														Subtotal = $672,441

Issue Date FY: 2016 ( Subtotal = $655,442 )
2016	2016	UNIVERSITY OF CALIFORNIA-SAN FRANCISCO	BOX 0812	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	1	7/20/2016	NEW	$655,442
														Subtotal = $655,442

Grand Total All Awards = $3,282,887

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Impact of Web-Based Lifestyle Interventions on Prostate Cancer Prognosis

Award Number: R01CA207749

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2016

PERIOD OF PERFORMANCE END DATE: 07/31/2024

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