Tuesday, March 3, 2026 3/3/2026

Biomarker Approaches to Individualizing Systemic Therapy for High Risk Prostate Cancer

Award Number: R01CA240582
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Biomarker Approaches to Individualizing Systemic Therapy for High Risk Prostate Cancer - Each year, over 1 million new patients are diagnosed with prostate cancer (PCa) worldwide, and over 300,000 men die of this disease. High risk PCa accounts for the vast majority of PCa deaths. The standard of care for high risk PCa was set by RTOG 92-02, a phase III trial that demonstrated a reduction in disease recurrence and an improvement in PCa-specific survival with radiation therapy (RT) plus long-term androgen deprivation therapy (LTADT, 28 months), compared to RT with short-term ADT (STADT, 4 months). Despite this advance, both overtreatment and undertreatment are acute clinical problems in this patient population. In this trial, 50% of patients were ultimately not cured with RT + LTADT. If this subset of patients had been identified with prognostic biomarkers, they could have received therapy more suited to their aggressive disease, including chemotherapy and novel targeted agents. On the other hand, 30% of men were cured with RT + STADT alone, and could have avoided 24 unnecessary months of exposure to ADT and its toxic side effects. Surprisingly, PCa is one of the few common cancers in which molecular biomarkers are not routinely used to guide therapeutic decisions. To address these unmet needs, we propose to develop and validate clinically useful and cost-effective prognostic and predictive biomarkers for high-risk PCa patients treated with RT, by applying a clinical-grade high-density oligonucleotide array on a unique set of tumor samples from three landmark phase III trials (RTOG 92-02, 99-02, and 94-13). Our research team, combining expertise in PCa, prognostic and predictive biomarker signature identification and validation, bioinformatics, and decision analysis, will: (1) Optimize a prognostic classifier that integrates genomic and clinicopathologic data for PCa patients treated with RT, allowing selection of men with high-risk PCa who would benefit from treatment intensification in future trials, (2) Derive and validate an integrated genomic-clinicopathologic predictor of response to LTADT vs. STADT, a therapeutic duration signature that would allow differentiation of patients who should require LTADT vs. those who are likely to be cured with STADT alone, and (3) Determine the health benefits and cost- effectiveness of using genomic-clinicopathologic classifiers to personalize therapy in men with high-risk PCa. Successful completion of these aims would result in cost-effective prognostic and predictive clinical-grade biomarkers developed on a CLIA-compliant platform that would have an immediate impact on the clinical management of men with high-risk PCa, transforming current treatment paradigms for these patients.


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	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	5	11/25/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $625,840 )
2024	2024	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	001	5	6/5/2024	NON-COMPETING CONTINUATION	$625,840
2024	2023	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	4	5/20/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $625,840

Issue Date FY: 2023 ( Subtotal = $655,198 )
2023	2023	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	6/15/2023	NON-COMPETING CONTINUATION	$655,198
														Subtotal = $655,198

Issue Date FY: 2022 ( Subtotal = $675,198 )
2022	2022	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	002	3	7/21/2022	SUPPLEMENT FOR EXPANSION	$54,292
2022	2022	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	001	3	7/20/2022	NON-COMPETING CONTINUATION	$620,906
2022	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	1	4/28/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $675,198

Issue Date FY: 2021 ( Subtotal = $815,730 )
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	002	2	6/29/2021	SUPPLEMENT FOR EXPANSION	$110,397
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	1	6/4/2021	SUPPLEMENT FOR EXPANSION	$71,828
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	001	2	6/17/2021	NON-COMPETING CONTINUATION	$633,505
														Subtotal = $815,730

Issue Date FY: 2020 ( Subtotal = $651,833 )
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	1	3/10/2020	NEW	$651,833
														Subtotal = $651,833

Grand Total All Awards = $3,423,799

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Biomarker Approaches to Individualizing Systemic Therapy for High Risk Prostate Cancer

Award Number: R01CA240582

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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