History of Changes for Study: NCT03716739

Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

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Study Record Versions

Version	Submitted Date	Changes
1	October 22, 2018	None (earliest Version on record)
2	November 5, 2018	Sponsor/Collaborators, Study Identification, Study Status, Contacts/Locations and Oversight
3	January 14, 2019	Study Status
4	May 30, 2019	Recruitment Status, Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Eligibility and Study Description
5	June 16, 2020	Study Status
6	August 2, 2021	Study Status
7	July 29, 2022	Contacts/Locations and Study Status
8	June 26, 2023	Contacts/Locations and Study Status
9	January 18, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	18-733
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
Secondary IDs:	1R01AG060539-01 [U.S. NIH Grant/Contract]

Study Status


Record Verification:	January 2024
Overall Status:	Recruiting
Study Start:	March 19, 2019
Primary Completion:	July 1, 2024 [Anticipated]
Study Completion:	October 1, 2024 [Anticipated]

First Submitted:	October 2, 2018
First Submitted that Met QC Criteria:	October 22, 2018
First Posted:	October 23, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	January 18, 2024
Last Update Posted:	January 19, 2024 [Actual]

Sponsor/Collaborators


Sponsor:	Dana-Farber Cancer Institute
Responsible Party:	Principal Investigator Investigator: Shalender Bhasin, MD Official Title: Principal Investigator Affiliation: Dana-Farber Cancer Institute
Collaborators:	National Institute on Aging (NIA)

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

Conditions


Conditions:	Prostate Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Supportive Care
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	142 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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 Names: 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 Names: Inactive comparator

Outcome Measures


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.

Eligibility


Minimum Age:	40 Years
Maximum Age:
Sex:	Male
Gender Based:	Yes
	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

Contacts/Locations


Central Contact Person:	Shalender Bhasin, MD Telephone: 617-525-9150 Email: sbhasin@partners.org
Central Contact Backup:	Fabiola Privat Telephone: 617-525-9132 Email: fprivat@bwh.harvard.edu
Study Officials:	Shalender Bhasin, MD Principal Investigator Brigham and Women's Hospital
Locations:	United States, Maryland
	Johns Hopkins University [Recruiting] Baltimore, Maryland, United States, 21287 Contact:Contact: Julia Faranetta 410-502-2776 jfarane1@jhmi.edu Contact:Principal Investigator: Arthur Burnett, MD
	United States, Massachusetts
	Brigham and Women's Hospital [Recruiting] Boston, Massachusetts, United States, 02115 Contact:Contact: Shalender Bhasin, MD 617-525-9040 sbhasin@partners.org Contact:Contact: Nancy Latham, PhD nklatham@bwh.harvard.edu Contact:Principal Investigator: Shalender Bhasin, MD
	Dana Farber Cancer Institute [Recruiting] Boston, Massachusetts, United States, 02115 Contact:Contact: Shalender Bhasin Contact:Contact: Nancy Latham, PhD nklatham@bwh.harvard.edu Contact:Principal Investigator: Shalender Bhasin, MD

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