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Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Testosterone Cypionate 100 MG/ML
Placebo
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins UniversityRecruiting
  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

Weekly IM administration of 100 mg testosterone cypionate for 12 weeks.

Weekly IM administration of placebo for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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).
Change in mood
Mood and well-being will be assessed by PANAS.
Change in physical function
Physical function will be assessed by measuring stair climbing power with and without a standardized load, walking speed.
Change in self-reported physical function
Self-reported physical function will be assessed using physical function domain of MOS SF-36 (PF10)
Change in maximal voluntary strength
Maximal voluntary strength in the leg press exercise by the 1-RM method.
Change in lean body mass
Lean body mass using dual energy X-ray absorptiometry (DXA).
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.
Change in aerobic capacity
Aerobic capacity will be assessed by measuring VO2 peak.

Full Information

First Posted
October 2, 2018
Last Updated
June 26, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03716739
Brief Title
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
Official Title
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
Weekly IM administration of 100 mg testosterone cypionate for 12 weeks.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Weekly IM administration of placebo for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Testosterone Cypionate 100 MG/ML
Other Intervention Name(s)
Depo-Testosterone
Intervention Description
100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive comparator
Intervention Description
Placebo administered by intramuscular injection weekly for 12 weeks.
Primary Outcome Measure Information:
Title
Change in sexual activity
Description
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.
Time Frame
5-8 months
Secondary Outcome Measure Information:
Title
Change in erectile function
Description
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.
Time Frame
5-8 months
Title
Change in sexual desire
Description
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
Time Frame
5-8 months
Title
Change in energy level
Description
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).
Time Frame
5-8 months
Title
Change in mood
Description
Mood and well-being will be assessed by PANAS.
Time Frame
5-8 months
Title
Change in physical function
Description
Physical function will be assessed by measuring stair climbing power with and without a standardized load, walking speed.
Time Frame
5-8 months
Title
Change in self-reported physical function
Description
Self-reported physical function will be assessed using physical function domain of MOS SF-36 (PF10)
Time Frame
5-8 months
Title
Change in maximal voluntary strength
Description
Maximal voluntary strength in the leg press exercise by the 1-RM method.
Time Frame
5-8 months
Title
Change in lean body mass
Description
Lean body mass using dual energy X-ray absorptiometry (DXA).
Time Frame
5-8 months
Title
Change in hormone Levels
Description
Total testosterone, DHT and estradiol will be measured using LC-MS/MS in a CDC-certified laboratory, free testosterone by equilibrium dialysis.
Time Frame
5-8 months
Title
Change in aerobic capacity
Description
Aerobic capacity will be assessed by measuring VO2 peak.
Time Frame
5-8 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males with a history of prostate cancer who have undergone prostatectomy.
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shalender Bhasin, MD
Phone
617-525-9150
Email
sbhasin@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Fabiola Privat
Phone
617-525-9132
Email
fprivat@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Faranetta
Phone
410-502-2776
Email
jfarane1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Arthur Burnett, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin, MD
Phone
617-525-9040
Email
sbhasin@partners.org
First Name & Middle Initial & Last Name & Degree
Nancy Latham, PhD
Email
nklatham@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin
First Name & Middle Initial & Last Name & Degree
Nancy Latham, PhD
Email
nklatham@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin, MD

12. IPD Sharing Statement

Learn more about this trial

Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

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