Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

Prostate Cancer Clinical Trial

Official title:

Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716739
• Other study ID #: 18-733
• Secondary ID: 1R01AG060539-01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 19, 2019
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: Shalender Bhasin, MD
• Phone: 617-525-9150
• Email: sbhasin[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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
• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Testosterone Cypionate 100 MG/ML
100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.
• Placebo
Placebo administered by intramuscular injection weekly for 12 weeks.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sexual activity	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.	5-8 months
Secondary	Change in erectile function	Erectile function will be assessed by IIEF. The International Index of Erectile Function (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.	5-8 months
Secondary	Change in sexual desire	Sexual desire will be assessed by DeRogatis Inventory of Sexual Function. HRQOL 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 HRQOL	5-8 months
Secondary	Change in energy level	Energy level will be 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 score indicate lower energy (or more tiredness0 and higher scores indicate more energy (less tiredness).	5-8 months
Secondary	Change in mood	Mood and well-being will be assessed by PANAS.	5-8 months
Secondary	Change in physical function	Physical function will be assessed by measuring stair climbing power with and without a standardized load, walking speed.	5-8 months
Secondary	Change in self-reported physical function	Self-reported physical function will be assessed using physical function domain of MOS SF-36 (PF10)	5-8 months
Secondary	Change in maximal voluntary strength	Maximal voluntary strength in the leg press exercise by the 1-RM method.	5-8 months
Secondary	Change in lean body mass	Lean body mass using dual energy X-ray absorptiometry (DXA).	5-8 months
Secondary	Change in hormone Levels	Total testosterone, DHT and estradiol will be measured using LC-MS/MS in a CDC-certified laboratory, free testosterone by equilibrium dialysis.	5-8 months
Secondary	Change in aerobic capacity	Aerobic capacity will be assessed by measuring VO2 peak.	5-8 months