Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 3
- 主要终点
- PSA Recurrence
研究概览
简要总结
The purpose of this phase II trial is to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related quality of life in men with prostate cancer who have undergone radical prostatectomy.
详细描述
The overall objective is to conduct a proof-of-concept double-blind, placebo-controlled, parallel group, randomized trial to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency (sexual symptoms, low energy, and physical dysfunction) and overall health-related quality of life in men with prostate cancer who have undergone radical prostatectomy for organ-localized disease (pT2,N0,M0), Gleason score < 7 (3+4), who have undetectable PSA (<0.1 ng/mL using a sensitive PSA assay) for > 2 years after radical prostatectomy, and who have androgen deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with prostate cancer, who have Stage pT2, N0, M0 lesions (confined to the gland); Combined Gleason score of 7 (3+4 elements) or less; Preoperative PSA less than 10 ng/ml; Stable and undetectable PSA level (PSA less than 0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL) for at least two years after radical prostatectomy.
- •Age: 40 years and older
- •Presence of symptoms related to sexual dysfunction, fatigue/low vitality, or physical dysfunction.
- •An average of two fasting, early morning serum testosterone levels, measured by LC-MS/MS, less than 275 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL. middle-aged and older men with mean testosterone levels > 300 ng/dL.
- •Ability and willingness to provide informed consent
排除标准
- •Men who have undergone radiation therapy
- •Men receiving androgen deprivation therapy will be excluded.
- •Hemoglobin <10 g/dL or >16.5 g/dL
- •Severe untreated sleep apnea
- •Allergy to sesame oil
- •Uncontrolled heart failure
- •Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
- •Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal;
- •Hemoglobin A1c >7.5% or diabetes requiring insulin therapy
- •Body mass index (BMI) >40 kg/m2
- •Untreated depression. Subjects with depression who have been on stable anti-depressant medication, or undergoing CBT for more than three months are eligible.
- •Men with axis I psychiatric disorder, such as schizophrenia, will be excluded.
- •Subjects who have used the following medications within the past 6 months: testosterone, DHEA, estrogens, GnRH analogs, antiandrogens, spironolactone, ketoconazole, rhGH, megestrol acetate, prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks
研究组 & 干预措施
Treatment Arm
Weekly IM administration of 100 mg testosterone cypionate for 12 weeks.
干预措施: Testosterone Cypionate 100 MG/ML (Drug)
Control Arm
Weekly IM administration of placebo for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
PSA Recurrence
时间窗: 5-8 months
The proportion of enrolled participations with PSA recurrence.
Change in sexual activity
时间窗: 5-8 months
Change in sexual activity is assessed by the Psychosexual Daily Questionnaire (PDQ), question 4. Subjects complete the 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 desire, sexual enjoyment, and mood are rated on a 7-point Likert-type scale from 0 to 7, with 0 indicating none and 7 indicating high. Activity is assessed using a checklist. Subjects record whether they had sexual daydreams; anticipation of sex; flirting; sexual interactions; and erection, masturbation, intercourse, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for analysis. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score is 0 if no activity has taken place. Higher values indicate more activity and lower values indicate lower activity.
Number of Participants With Biochemical Recurrence of Prostate Cancer
时间窗: the 12-week treatment and the 3-month follow-up
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.
Change From Baseline in Overall Sexual Activity, Assessed Using Psychosexual Diary Questionnaire (PDQ) Question 4
时间窗: Week 6, Week 12
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.
次要结局
- Change in PSA(Baseline to 5-8 months)
- Clinical Disease Recurrence(5-8 months)
- Change in sexual desire(5-8 months)
- Change in erectile function(5-8 months)
- Change in energy level(5-8 months)
- Change in mood(5-8 months)
- Change in physical function(5-8 months)
- Change in self-reported physical function(5-8 months)
- Change in maximal voluntary strength(5-8 months)
- Change in lean body mass(5-8 months)
- Change in hormone Levels(5-8 months)
- Change in aerobic capacity(5-8 months)
- Change in PSA(Week 12)
- Change From Baseline in Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS)(Week 6, Week 12)
- Change From Baseline in Hemoglobin(Week 6, Week 12)
- Change From Baseline in Hematocrit(Week 6, Week 12)
- Number of Participants With Erythrocytosis in the Two Study Arms(Week 12)
- Number of Participants With Clinical Prostate Cancer Recurrence in the Two Study Arms(Week 12)
- Change From Baseline in Sexual Desire, Assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire(Week 6, Week 12)
- Change in Erectile Function Assessed by the International Index of Erectile Function (IIEF) Questionnaire.(Week 6, Week 12)
- Change in Fat Body Mass(Week 12)
- Change in Energy Level, Assessed Using the Hypogonadism Energy Diary (HED)(Week 6, Week 12)
- Change in Mood, Assessed by the Positive and Negative Affect Schedule (PANAS)(Week 6, Week 12)
- 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)(Week 6, Week 12)
- Change From Baseline in Self-reported Physical Function, Assessed Using the Physical Function Component of MOS SF-36 (PF10)(Week 6, Week 12)
- Change From Baseline in Performance-based Physical Function, Assessed by Measuring Loaded Stair Climbing Power(Week 12)
- Change From Baseline in Chest Press Strength(Week 12)
- Change From Baseline in Leg Press Strength(Week 12)
- Change in Aerobic Capacity (VO2peak) Achieved During Cardiopulmonary Exercise Testing(Week 12)
- Change in Lean Body Mass(Week 12)
研究者
Shalender Bhasin, MD
Principal Investigator
Dana-Farber Cancer Institute