Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

The primary safety endpoint is the number of participants with biochemical recurrence of prostate cancer. Biochemical recurrence is defined as two or more consecutive serum PSA levels of 0.2 ng/mL or higher.

The primary efficacy endpoint is the change from baseline in overall sexual activity, assessed using Psychosexual Diary Questionnaire (PDQ) Question 4. Subjects complete the PDQ questionnaire daily for 7 consecutive days before each visit. The PDQ covers 3 domains:1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity (PDQ-4) is assessed using a checklist of 12 sexual activities including sexual interactions, masturbation, intercourse, erection, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for each of the sexual activities. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score ranges from 0 to 12, with 0 indicating no activity had taken place that week and with higher values indicating more sexual activity.

The secondary safety endpoint is change in PSA levels. Change from baseline in PSA could not be computed because the majority of the participants had undetectable PSA levels at baseline and post-baseline. Here, the number of participants with various PSA levels is reported.

The secondary safety endpoint is the change from baseline in lower urinary tract symptoms, ascertained using the International Prostate Symptom Score (IPSS). The IPSS is a validated 8-question survey (7 symptom questions, 1 quality-of-life question) used to assess the severity of lower urinary tract symptoms (LUTS) associated with BPH, ranging from 0-35, with a higher score indicating a more severe negative symptoms.

The secondary safety endpoint is the change from baseline in hemoglobin levels.

The secondary safety endpoint is the change from baseline in hematocrit levels.

The secondary safety endpoint is the number of participants with erythrocytosis (confirmed hemoglobin > 18.0 g/dL) in the two study arms.

The secondary safety endpoint is the number of participants with clinical prostate cancer recurrence in the two study arms.

The secondary efficacy endpoint is sexual desire, assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire. The DISF evaluates an individual's sexual health across five primary domains: sexual cognition/fantasy, arousal, behavior/experience, orgasm, and sexual drive/relationship. The Sexual Desire (SD) subset assesses an individual's subjective libido and frequency of sexual drive. The Sexual Desire score can range from 0 to 33, with a higher score indicating more sexual desire.

The secondary efficacy endpoint is erectile function will be assessed by the International Index of Erectile Function (IIEF) Questionnaire. The IIEF is a 15-item questionnaire that covers 4 domains of sexual function: erectile function, sexual desire, orgasmic function, and intercourse satisfaction. Each question has a potential score of 0 to 5 for a maximal score of 75 for the entire scale. Our focus in this study is on erectile function domain score, which can range from 0 to 30, lower scores indicating poor erectile function, and higher score indicating better erectile function.

The secondary efficacy endpoint is energy level, assessed using the Hypogonadism Energy Diary (HED). The total HED scale score is the sum of each of the six item weekly scores, with higher scores corresponding to greater energy level. The HED total score is linearly transformed to a scale of 0-100. Lower scores indicate lower energy (or more tiredness) and higher scores indicate more energy (less tiredness).

Mood and well-being will be assessed by the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item self-report measure to assess positive affect (PA) and negative affect (NA), with scores ranging from 10 to 50 for both the PA score and the NA score. For the PA score (10-50), higher scores represent higher levels of positive emotions, engagement, and enthusiasm. For the NA score (10-50), higher scores indicate higher levels of negative engagement, distress, and anxiety.

The secondary efficacy endpoint is change from baseline in prostate cancer-related quality of life measured using the hormonal and sexual domains of the Expanded Prostate Cancer Index Composite (EPIC). Expanded Prostate Cancer Index Composite Instrument (EPIC-26) for Measuring Health-Related Quality of Life Among Prostate Cancer Survivors EPIC QOL is a 26-item questionnaire that assesses quality of life in 5 domains: urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domain scores. All domains for EPIC-26 are reported on a 0 to 100 score, with higher scores representing favorable Health-Related Quality of Life (HRQOL).

The secondary efficacy endpoint is change from baseline self-reported physical function, assessed using the physical function component of MOS SF-36 (PF10). The PF-10 (Physical Functioning Scale) is the 10-item subscale within the MOS SF-36 assessing the extent to which health limits physical activities, such as self-care, walking, and lifting. Scores range from 0 to 100, where higher numbers mean better physical function and fewer limitations.

The secondary efficacy endpoint is change from baseline in performance-based physical function, assessed by measuring loaded stair climbing power.

The secondary efficacy endpoint is the change from baseline in Chest Press Max weight

The secondary efficacy endpoint is the change from baseline in Leg Press Max weight

The secondary efficacy endpoint is aerobic capacity (VO2peak) achieved during cardiopulmonary exercise testing.

Change from baseline in whole body, appendicular, and trunk lean tissue mass measured using dual energy X-ray absorptiometry (DXA).

Change from baseline in whole body, appendicular, and trunk fat tissue mass measured using dual energy X-ray absorptiometry (DXA).