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Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

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ClinicalTrials.gov Identifier: NCT03716739
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Shalender Bhasin, MD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Testosterone Cypionate 100 MG/ML Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024


Arm Intervention/treatment
Active Comparator: Treatment Arm
Weekly IM administration of 100 mg testosterone cypionate for 12 weeks.
Drug: Testosterone Cypionate 100 MG/ML
100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.
Other Name: Depo-Testosterone

Placebo Comparator: Control Arm
Weekly IM administration of placebo for 12 weeks.
Drug: Placebo
Placebo administered by intramuscular injection weekly for 12 weeks.
Other Name: Inactive comparator




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in erectile function [ Time Frame: 5-8 months ]
    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.

  2. Change in sexual desire [ Time Frame: 5-8 months ]

    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


  3. Change in energy level [ Time Frame: 5-8 months ]
    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).

  4. Change in mood [ Time Frame: 5-8 months ]
    Mood and well-being will be assessed by PANAS.

  5. Change in physical function [ Time Frame: 5-8 months ]
    Physical function will be assessed by measuring stair climbing power with and without a standardized load, walking speed.

  6. Change in self-reported physical function [ Time Frame: 5-8 months ]
    Self-reported physical function will be assessed using physical function domain of MOS SF-36 (PF10)

  7. Change in maximal voluntary strength [ Time Frame: 5-8 months ]
    Maximal voluntary strength in the leg press exercise by the 1-RM method.

  8. Change in lean body mass [ Time Frame: 5-8 months ]
    Lean body mass using dual energy X-ray absorptiometry (DXA).

  9. Change in hormone Levels [ Time Frame: 5-8 months ]
    Total testosterone, DHT and estradiol will be measured using LC-MS/MS in a CDC-certified laboratory, free testosterone by equilibrium dialysis.

  10. Change in aerobic capacity [ Time Frame: 5-8 months ]
    Aerobic capacity will be assessed by measuring VO2 peak.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males with a history of prostate cancer who have undergone prostatectomy.
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716739


Contacts
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Contact: Shalender Bhasin, MD 617-525-9150 sbhasin@partners.org
Contact: Sara M Bator 617-525-9132 sbator@bwh.harvard.edu

Locations
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United States, California
City of Hope Not yet recruiting
Duarte, California, United States, 91010
Contact: Tanya Dorff, MD    626-218-9200      
Contact: Gildardo Barron         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Shalender Bhasin, MD    617-525-9040    sbhasin@partners.org   
Contact: Brooke F Brawley       bbrawley@bwh.harvard.edu   
Principal Investigator: Shalender Bhasin, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Shalender Bhasin         
Contact: Brooke Brawley       bbrawley@bwh.harvard.edu   
Principal Investigator: Shalender Bhasin, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Shalender Bhasin, MD Brigham and Women's Hospital

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Responsible Party: Shalender Bhasin, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03716739     History of Changes
Other Study ID Numbers: 18-733
1R01AG060539-01 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Methyltestosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents