Trial Outcomes & Findings for Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer (NCT NCT02168062)

NCT ID: NCT02168062

Last Updated: 2020-07-23

Results Overview

The absolute change from baseline in percentage body fat after 12 months of study participation for participants in the randomized cohort was measured using a bioelectrical impedance analyzer and between group comparisons were performed using the Wilcoxon-rank-sum test.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 57 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2020-07-23

Participant Flow

This study included a small, non-randomized pilot cohort of 8 patients receiving concurrent chemohormonal therapy who were enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population but were not included in the final group comparisons.

Participant milestones

Measure	Arm I (Standard of Care) Patients receive leuprolide acetate subcutaneous (SC) or intramuscular (IM), or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Non-Randomized Pilot Cohort A non-randomized pilot cohort receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.
Overall Study STARTED	23	26	8
Overall Study COMPLETED	23	26	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies Triptorelin Pamoate: Given IM	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies Triptorelin Pamoate: Given IM	Non-Randomized Pilot Cohort n=8 Participants A non-randomized pilot cohort of 20 patients receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.	Total n=57 Participants Total of all reporting groups
Age, Customized 50-60 years old	4 participants n=5 Participants	7 participants n=7 Participants	3 participants n=5 Participants	14 participants n=4 Participants
Age, Customized 61-70 years old	9 participants n=5 Participants	11 participants n=7 Participants	4 participants n=5 Participants	24 participants n=4 Participants
Age, Customized 71-80 years old	8 participants n=5 Participants	7 participants n=7 Participants	1 participants n=5 Participants	16 participants n=4 Participants
Age, Customized 81-90 years old	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	26 Participants n=7 Participants	8 Participants n=5 Participants	57 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	22 Participants n=7 Participants	6 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	21 Participants n=7 Participants	4 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment United States	23 participants n=5 Participants	26 participants n=7 Participants	8 participants n=5 Participants	57 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 12 months

The absolute change from baseline in percentage body fat after 12 months of study participation for participants in the randomized cohort was measured using a bioelectrical impedance analyzer and between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Percentage Body Fat Mass as Measured by Bioelectrical Impedance Analyzer (Randomized Cohort)	-1 percentage of body fat mass Interval -28.5 to 11.6	6.8 percentage of body fat mass Interval -20.2 to 17.4

PRIMARY outcome

Timeframe: Up to 12 months

The percentage of participants in the pilot, non-randomized cohort who completed clinic visits for Supportive Therapy in Androgen Deprivation (STAND) will be reported to assess feasibility.

Outcome measures

Measure	Arm I (Standard of Care) n=8 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Percentage of Participants in the Non-randomized, Pilot, Cohort Who Completed Clinic Visits	62.5 percentage of participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in systolic and diastolic blood pressure from the baseline to month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Blood Pressure (Randomized Cohort) Systolic Blood Pressure	10 mmHg Interval -11.0 to 46.0	9 mmHg Interval -25.0 to 27.0
Absolute Change in Blood Pressure (Randomized Cohort) Diastolic Blood Pressure	2 mmHg Interval -10.0 to 37.0	-3 mmHg Interval -16.0 to 13.0

SECONDARY outcome

Timeframe: Up to 12 months

Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in body weight from the baseline to month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Body Weight (Randomized Cohort)	0.8 kilograms Interval -8.4 to 15.0	2.6 kilograms Interval -11.3 to 16.8

SECONDARY outcome

Timeframe: Up to 12 months

Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in percentage of body fat from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Percentage of Body Fat (Randomized Cohort)	-1 percentage of body fat Interval -28.5 to 11.6	6.8 percentage of body fat Interval -20.2 to 17.4

SECONDARY outcome

Timeframe: Up to 12 months

Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in waist circumference from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Waist Circumference (Randomized Cohort)	5 centimeters Interval -8.0 to 14.0	1.7 centimeters Interval -4.0 to 9.3

SECONDARY outcome

Timeframe: Up to 12 months

Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in percentage hemoglobin A1c from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Hemoglobin A1c (Randomized Cohort)	-0.1 percentage Interval -0.8 to 0.7	-0.1 percentage Interval -0.8 to 0.2

SECONDARY outcome

Timeframe: Up to 12 months

Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in insulin resistance scores from the baseline to the month 12 assessment. Insulin resistance scores were calculated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). This calculation marks for both the presence and extent of any insulin resistance that participants might currently express. The HOMA-IR is an assessment using insulin and glucose lab values to generate an insulin resistance score. A healthy score range is 1.0 (0.5-1.4). A score of less than 1.0 means you are insulin-sensitive which is optimal. A score above 1.9 indicates early insulin resistance. A score above 2.9 indicates significant insulin resistance. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Insulin Resistance Score (Randomized Cohort)	0 score on a scale Interval -1.5 to 5.4	-0.5 score on a scale Interval -3.1 to 3.6

SECONDARY outcome

Timeframe: Up to 12 months

Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in fasting lipids which includes total cholesterol, low density lipoprotein, High density lipoprotein, and triglycerides levels from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Fasting Lipids (Randomized Cohort) Total Cholesterol	4 milligram per deciliter (mg/dL) Interval -313.0 to 134.0	-1 milligram per deciliter (mg/dL) Interval -102.0 to 138.0
Absolute Change in Fasting Lipids (Randomized Cohort) Low density lipoprotein	-4 milligram per deciliter (mg/dL) Interval -26.0 to 86.0	-4 milligram per deciliter (mg/dL) Interval -64.0 to 50.0
Absolute Change in Fasting Lipids (Randomized Cohort) High density lipoprotein	5 milligram per deciliter (mg/dL) Interval -18.0 to 46.0	7 milligram per deciliter (mg/dL) Interval -70.4 to 21.0
Absolute Change in Fasting Lipids (Randomized Cohort) Triglycerides	19 milligram per deciliter (mg/dL) Interval -79.0 to 188.0	-3 milligram per deciliter (mg/dL) Interval -135.0 to 182.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Only a small subset of patients reported both baseline and 12 month data.

Metabolic impact for participants from baseline to 12 months was measured using an exercise pattern questionnaire. The questionnaire measured self-reported average total time per week over the past year the participant participated in various physical activities such as walking, tennis, yoga, swimming, etc. Twelve response options for each activity are as follows: None, 1-4 minutes (min), 5-19 min, 20-39 min, 40-89 min, 1.5 hours, 2-3 hours, 4-6 hours, 7-10 hours, 11-20 hours, 21-30 hours, 31-40 hours, 40+ hours. The amount of time per week spent on each activity was converted to a hourly scale and the absolute change between baseline and month 12 times were calculated for each participant. The median absolute change in hours per week were compared for each of the 6 activity categories: non-vigorous, moderate, moderate-vigorous, vigorous, and total physical activity and total moderate and vigorous activity combined.

Outcome measures

Measure	Arm I (Standard of Care) n=15 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=12 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Hours Per Week of Physical Activity Category as Measured by the Exercise Pattern Assessment (Randomized Cohort) Non-vigorous physical activity	-0.62 hours per week Interval -10.0 to 6.54	-1.03 hours per week Interval -7.3 to 2.3
Absolute Change in Hours Per Week of Physical Activity Category as Measured by the Exercise Pattern Assessment (Randomized Cohort) Moderate physical activity	0.00 hours per week Interval -7.0 to 7.0	0.00 hours per week Interval -8.5 to 2.5
Absolute Change in Hours Per Week of Physical Activity Category as Measured by the Exercise Pattern Assessment (Randomized Cohort) Vigorous physical activity	-0.20 hours per week Interval -26.22 to 37.46	-0.02 hours per week Interval -5.0 to 2.96
Absolute Change in Hours Per Week of Physical Activity Category as Measured by the Exercise Pattern Assessment (Randomized Cohort) Total physical activity	-.30 hours per week Interval -19.68 to 39.26	-.90 hours per week Interval -6.58 to 2.3
Absolute Change in Hours Per Week of Physical Activity Category as Measured by the Exercise Pattern Assessment (Randomized Cohort) Total Moderate-Vigorous physical activity (MVPA)	-0.30 hours per week Interval -19.22 to 39.46	-0.08 hours per week Interval -5.54 to 2.5

SECONDARY outcome

Timeframe: Up to 12 months

Population: Only a small subset of patients reported both baseline and 12 month data.

Metabolic impact for participants in each group from baseline to 12 months was measured by using an ambulatory accelerometer worn by participants around their waist for 7 consecutive days. Participants were required at least 3 days of valid wear time, defined as >= 10 hours of wear per day. The accelerometer measured movement intensity and recorded vertical acceleration as "counts," providing an indication of the intensity of physical activity associated with locomotion. Non-wear time was identified using Troiano 2007 default settings in the ActiLife v6.13.3 software. The amount of time participants were engaged in moderate to vigorous physical activities (MVPA) was measured by accelerometer as counts per minute (moderate activity = 2020-5998 counts per minute, and vigorous activity = 5999 or more counts per minute). Counts are then transformed into minutes per day with a total range of 0-1440 minutes. The median absolute change in average MVPA was compared between the two groups.

Outcome measures

Measure	Arm I (Standard of Care) n=3 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=8 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Average Moderate to Vigorous Physical Activity (MVPA) as Measured by an Ambulatory Accelerometer Assessment (Randomized Cohort)	-18.40 minutes per day Interval -45.46 to 39.5	-2.36 minutes per day Interval -26.3 to 5.9

SECONDARY outcome

Timeframe: Up to 12 months

The absolute change in bone density t-scores from the baseline to the month 12 assessment for participants in the randomized cohort was measured using bone density at the lumbar spine, bone density at the femoral neck, and bone density at the total hip. A T-score of -1.0 or above is normal bone density. A T-score between -1.0 and -2.5 indicates low bone density or osteopenia. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Bone Density T-score (Randomized Cohort) Bone density at the lumbar spine	-2.0 t-score Interval -3.5 to 0.1	-0.40 t-score Interval -1.8 to 0.6
Absolute Change in Bone Density T-score (Randomized Cohort) Bone density at the femoral neck	-0.25 t-score Interval -2.3 to 1.9	-0.20 t-score Interval -2.1 to 1.2
Absolute Change in Bone Density T-score (Randomized Cohort) Bone density of total hip	-0.20 t-score Interval -2.3 to 0.1	-0.10 t-score Interval -0.7 to 0.0

SECONDARY outcome

Timeframe: Up to 12 months

The absolute change in bone health parameters as measured by the serum 25-(OH) vitamin D level from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Serum 25-(OH) Vitamin D (Randomized Cohort)	3.60 nanograms per milliliter (ng/mL) Interval -14.0 to 24.0	8.10 nanograms per milliliter (ng/mL) Interval -21.0 to 20.0

SECONDARY outcome

Timeframe: Up to 12 months

The absolute change in scores on the Patient Health Questionnaire-9 (PHQ-9) from baseline after 12 months of study participation for participants was used to measure depression symptoms with a higher number indicating a greater percentage of change in scores. The total Patient Health Questionnaire-9 (PHQ-9) score is calculated by combining the responses of the participant on questions addressing how bothered the participant has been by various problems over the past 2 weeks. Each of the 9 items is scored on a scale of 0 ("Not bothered at all") to 4 ("Nearly every day"). A total score of 5-9='Mild Depression Symptoms", 10-4="Minor Depression, Major Depression (mild), or Dysthymia", 15-19="Major Depression, moderately severe", and >20="Major Depression".

Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Patient Health Questionnaire-9 (PHQ-9) Scores (Randomized Cohort)	0 score on a scale Interval -5.0 to 3.0	.50 score on a scale Interval -5.0 to 3.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Only a subset of patients reported both baseline and 12 month data.

The AFI measures a participants perceived effectiveness in functioning at time of assessment. Each of the 16 items consists of a 100 mm horizontal line anchored with opposite phrases from not at all (0 mm) to extremely well or a great deal (100 mm). Subjects are asked to place a mark on the line that best describes functioning in relation to specific activity. Scores for each item are determined by measuring distance from lower end of scale in millimeters. The total score on the instrument is computed by obtaining an average of 16 scales. The absolute change in score by group from baseline up to month 12 in Attention Function Index was used to measure perceived effectiveness in common activities requiring attention and working memory in daily life with a higher number indicating a greater absolute change in scores. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=15 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=11 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Attention Function Index (AFI) Scores (Randomized Cohort)	2.31 score on a scale Interval -27.75 to 26.62	-4 score on a scale Interval -15.26 to 10.44

SECONDARY outcome

Timeframe: Up to 12 months

Population: Only a subset of participants completed questionnaires at both baseline and 12 months.

The SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) and measures two composite outcomes assessing mental health composite score (MCS) and physical health composite scores (PCS). The PCS & MCS are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The absolute change in item score by group from baseline up to 12 months was used to assess the quality of life/psychosocial impact on the patients with a larger scores indicating a greater degree of change on physical and mental health. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=20 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=25 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in the 12-item Short Form Survey (SF-12) Assessment Item Scores for Patients in the Randomized Cohort Mental Composite Score	4.81 score on a scale Interval -8.46 to 11.9	-2.37 score on a scale Interval -7.37 to 4.03
Absolute Change in the 12-item Short Form Survey (SF-12) Assessment Item Scores for Patients in the Randomized Cohort Physical Composite Score	-2.90 score on a scale Interval -17.82 to 18.75	-1.60 score on a scale Interval -6.65 to 8.59

SECONDARY outcome

Timeframe: Up to 12 months

The absolute change in score by group from baseline up to month 12 on the International Prostate Symptom Score (IPSS) was used to measure the severity of lower urinary tract symptoms and erectile function with lower numbers indicating less change in symptoms. Seven questions with scores ranging from 1-5 are summed to create a total score. Scores of 1-7 indicate mild symptoms, scores of 8-19 indicate moderate symptoms, and scores of 20-35 indicate severe symptoms. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in International Prostate Symptom Score (IPSS) (Randomized Cohort)	2 score on a scale Interval -20.0 to 24.0	-2 score on a scale Interval -9.0 to 22.0

SECONDARY outcome

Timeframe: Up to 12 months

The absolute change in score by group from baseline up to month 12 on the International Prostate Symptom Score (IPSS) was used to measure the severity of lower urinary tract symptoms and erectile function. The last question on the IPSS can be looked at separately from the total score as it asks the participants to rate the overall quality of life due to their existing urinary symptoms on a scale of 0-6, with lower scores indicating a better quality of life. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Last Question on International Prostate Symptom Score (IPSS) (Randomized Cohort)	0 score on a scale Interval -3.0 to 2.0	0 score on a scale Interval -1.0 to 1.0

SECONDARY outcome

Timeframe: Up to 12 months

The absolute change in Hot Flash Related Daily Interference Scale from baseline to month 12 was used to measure the impact of occurrence of hot flashes on daily activities with higher numbers indicating a greater change in the interference of hot flashes with participant's quality of life. The HFRDIS is a 10-item scale measuring the degree hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was developed to include daily life activities specific to impact of hot flashes. Participants rate degree to which hot flashes have interfered with each item during previous week using a 0 (do not interfere) to 10 (completely interfere) point scale, with total score ranging from 0-100. Higher scores indicate higher interference and thus, greater impact on quality of life. Women without hot flashes are asked to mark 0 for each item. Group comparisons performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Hot Flash Related Daily Interference Scale Score (HFRDIS) (Randomized Cohort)	13 score on a scale Interval -22.0 to 67.0	4.5 score on a scale Interval -52.0 to 37.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Only a subset of patients reported both baseline and 12 month data.

The EPIC-26 was measured at baseline and month 12 to determine the impact of quality of life issues across 5 prostate cancer specific domains: Urinary incontinence, Urinary irritation, Bowel function, Sexual function, and Hormonal function and overall total quality of life. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL). Between group comparisons were performed using the Wilcoxon-rank-sum test

Outcome measures

Measure	Arm I (Standard of Care) n=25 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=20 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort) Total	-4.91 score on a scale Interval -25.53 to 17.1	-3.85 score on a scale Interval -11.54 to 11.27
Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort) Urinary incontinence	0 score on a scale Interval -37.75 to 39.5	0 score on a scale Interval -20.57 to 17.0
Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort) Urinary irritation	-5.00 score on a scale Interval -27.5 to 60.0	5.00 score on a scale Interval -5.0 to 25.0
Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort) Bowel function	0 score on a scale Interval -87.5 to 25.0	-4.17 score on a scale Interval -16.67 to 12.5
Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort) Sexual function	-12.50 score on a scale Interval -47.0 to 16.67	-2.08 score on a scale Interval -48.67 to 12.5
Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort) Hormonal Function	0 score on a scale Interval -41.25 to 12.5	-17.50 score on a scale Interval -35.0 to 25.0

SECONDARY outcome

Timeframe: Up to 12 months

The absolute change in Lee Fatigue Scale from baseline to month 12 was used to measure the impact of Fatigue on a participants quality of life. The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X" representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired"). Each line is 100 mm in length - thus, scores fall between 0 and 100. The instrument also possesses two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). The fatigue subscale score is calculated as the mean of the 13 fatigue items, and the energy subscale score is the mean of the 5 energy items. Higher scores on the fatigue subscale represent greater fatigue severity, and higher scores on the energy subscale indicate higher levels of energy. Between group comparisons were performed using the Wilcoxon-rank-sum test.

Outcome measures

Measure	Arm I (Standard of Care) n=23 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months. Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies	Arm II (STAND Clinic) n=26 Participants Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months. Behavioral Dietary Intervention: Receive individualized nutrition counseling Counseling: Receive individualized symptom management service counseling Educational Intervention: Review educational modules Exercise Intervention: Receive individualized exercise counseling Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given SC or IM Quality-of-Life Assessment: Ancillary studies
Absolute Change in Lee Fatigue Scale Scores (Randomized Cohort) Fatigue Scale	5.68 score on a scale Interval -36.09 to 33.38	3.15 score on a scale Interval -5.4 to 29.15
Absolute Change in Lee Fatigue Scale Scores (Randomized Cohort) Energy Scale	-0.10 score on a scale Interval -19.8 to 44.2	1.30 score on a scale Interval -15.6 to 27.4

Adverse Events

Arm I (Standard of Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (STAND Clinic)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Randomized Pilot Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Li Zhang, PhD

University of California, San Francisco

Phone: (415) 476-5339

Email: Li.Zhang@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place