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Improving Patient-Important Outcomes with Testosterone Replacement in Hypogonadal Men with a Prior History of Cancer

Award Number: R01CA239208
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/08/2019
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Improving Patient-Important Outcomes with Testosterone Replacement in Hypogonadal Men with a Prior History of Cancer - PROJECT SUMMARY/ABSTRACT The overall goal of this proposal is to evaluate the efficacy of testosterone replacement therapy in improving fatigue and other outcomes such as sexual function, quality of life, body composition, muscle strength and physical activity in a double-blind, randomized, placebo-controlled trial in young cancer survivors who report fatigue and have testosterone deficiency. Fatigue is one of the most prevalent and debilitating symptoms in men with cancer affecting 70-100% of patients irrespective of their age. Cancer-related fatigue is experienced by patients not only during active cancer treatment, but is also highly prevalent in cancer survivors who exhibit persistent fatigue months to years after the end of their treatment with the highest prevalence being in recipients of chemotherapy and/or radiation therapy. In addition to fatigue, sexual dysfunction is also highly prevalent in male cancer survivors. Male cancer survivors also have increased fat mass and decreased lean body mass, a phenotype that predisposes them to reduced muscle strength. This phenotype of fatigue, sexual dysfunction and adverse body composition is commonly encountered in non-cancer patient populations with testosterone deficiency, a condition which is also highly prevalent (50-90%) in cancer survivors. Pivotal trials of testosterone replacement therapy in non-cancer patient populations have shown an improvement in fatigue, sexual function and body composition in men randomized to testosterone compared with placebo. However, the efficacy of testosterone replacement therapy on cancer-related fatigue has not been studied. We propose a large, 9-month, double-blind, randomized, placebo-controlled trial in which: 1) we will compare the efficacy of weekly testosterone injections versus placebo in improving fatigue scores in cancer survivors who report fatigue and also have testosterone deficiency, 2) we will compare the effects of testosterone replacement versus placebo on sexual function, well-being, mood and quality of life, and 3) we will determine the effect of testosterone administration on body composition, muscle strength and physical activity compared with placebo. With an increase in longevity among cancer survivors and the growing recognition of the importance of symptom control in the lives of these patients, the proposed trial is likely to have a significant clinical impact in the management of patient-reported outcomes. If testosterone therapy is found to be efficacious in alleviating these symptoms, the clinicians will have available to them a therapeutic option that is relatively inexpensive, convenient to use and has a good safety record in young men.


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 = $517,115 )
2025	2025	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY	SEATTLE	WA	98108	KING	USA	Cancer Cause and Prevention Research	000	6	4/30/2025	NON-COMPETING CONTINUATION	$465,404
2025	2025	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY	SEATTLE	WA	98108	KING	USA	Cancer Cause and Prevention Research	001	6	5/22/2025	NON-COMPETING CONTINUATION	$51,711
														Subtotal = $517,115

Issue Date FY: 2024 ( Subtotal = $631,770 )
2024	2024	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY	SEATTLE	WA	98108	KING	USA	Cancer Cause and Prevention Research	000	5	7/24/2024	NON-COMPETING CONTINUATION	$631,770
														Subtotal = $631,770

Issue Date FY: 2023 ( Subtotal = $125,176 )
2023	2023	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY # 151F	SEATTLE	WA	98108	KING	USA	Cancer Cause and Prevention Research	000	4	5/17/2023	NON-COMPETING CONTINUATION	$125,176
														Subtotal = $125,176

Issue Date FY: 2022 ( Subtotal = $643,552 )
2022	2022	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY # 151F	SEATTLE	WA	98108	KING	USA	Cancer Cause and Prevention Research	000	3	5/2/2022	NON-COMPETING CONTINUATION	$643,552
														Subtotal = $643,552

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY # 151F	SEATTLE	WA	98108	KING	USA	Cancer Cause and Prevention Research	000	2	6/25/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $663,748 )
2020	2020	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY # 151F	SEATTLE	WA	98108	KING	USA	Cancer Cause and Prevention Research	000	2	7/24/2020	NON-COMPETING CONTINUATION	$663,748
														Subtotal = $663,748

Issue Date FY: 2019 ( Subtotal = $720,928 )
2019	2019	SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH	1660 S COLUMBIAN WAY BLDG 7	SEATTLE	WA	98108	KING	USA	Cancer Cause and Prevention Research	000	1	5/8/2019	NEW	$720,928
														Subtotal = $720,928

Grand Total All Awards = $3,302,289

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Improving Patient-Important Outcomes with Testosterone Replacement in Hypogonadal Men with a Prior History of Cancer

Award Number: R01CA239208

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/08/2019

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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