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Randomized Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer:

Award Number: R01CA272678
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2022
PERIOD OF PERFORMANCE END DATE: 07/04/2025

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Randomized Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer: - Abstract Widespread use of serum prostate-specific antigen (PSA) screening results in 50% of new cases of prostate cancer being diagnosed with low-grade localized disease. Standard of care for these cases is to defer immediate treatment in favor of active surveillance (AS), a low-toxicity management which entails close monitoring with PSA tests, repeat prostate biopsies and multi-parametric MRI (mpMRI). Around 30% of men on AS progress or electively undergo definitive treatment within two years of diagnosis. Efficacious low-cost, low-toxicity strategies to limit exit from AS are needed to reduce over-treatment and improve health-related quality of life (QOL). Accordingly, in this proposal we will test whether and how exercise alters prostate cancer molecular landscape. Using a two-arm RCT design, 122 men initiating AS (e.g., inactive, diagnostic biopsy <6 months) will be randomly allocated (1:1 ratio) to exercise therapy intervention (n=61) or usual care (plus general physical activity advice; n=61) for 12 months. Exercise therapy will consist of home-based, treadmill walking five days each week at 65-75% of their personal baseline exercise capacity. All sessions will be implemented using TeleMed-X, a novel telemedicine platform pioneered in our program. Our central hypothesis is that exercise therapy will reduce the number of nimbosus features to collectively inhibit clinical progression. This central hypothesis is tested in three distinct, but complementary aims: Aim 1. Determine effects of exercise therapy on molecular nimbosus hallmarks; Aim 2. Determine effects on the radiologic and pathologic nimbosus hallmarks; and Aim 3. Delineate the precision of estimating rates of clinical progression at 18 months.


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: 2026 ( Subtotal = $0 )
2026	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	3	11/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $839,781 )
2025	2025	BECKMAN RESEARCH INSTITUTE OF THE CITY OF HOPE	1500 DUARTE RD	DUARTE	CA	91010	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	001	4	9/18/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$839,781
2025	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	3	9/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $839,781

Issue Date FY: 2024 ( Subtotal = $658,881 )
2024	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	3	7/25/2024	NON-COMPETING CONTINUATION	$658,881
														Subtotal = $658,881

Issue Date FY: 2023 ( Subtotal = $679,692 )
2023	2023	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVENUE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	001	2	8/21/2023	NON-COMPETING CONTINUATION	$679,692
2023	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	1	12/13/2022	NEW	$0
														Subtotal = $679,692

Issue Date FY: 2022 ( Subtotal = $715,452 )
2022	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	1	9/15/2022	NEW	$715,452
														Subtotal = $715,452

Grand Total All Awards = $2,893,806

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Randomized Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer:

Award Number: R01CA272678

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2022

PERIOD OF PERFORMANCE END DATE: 07/04/2025

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