Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
Overview
- Phase
- Phase 2
- Intervention
- Testosterone Cypionate 100 MG/ML
- Conditions
- Prostate Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 136
- Locations
- 3
- Primary Endpoint
- PSA Recurrence
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Shalender Bhasin, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Treatment Arm
Weekly IM administration of 100 mg testosterone cypionate for 12 weeks.
Intervention: Testosterone Cypionate 100 MG/ML
Control Arm
Weekly IM administration of placebo for 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
PSA Recurrence
Time Frame: 5-8 months
The proportion of enrolled participations with PSA recurrence.
Change in sexual activity
Time Frame: 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.
Secondary Outcomes
- 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)