Clinical trial NCT03716739: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-10-23
Enrollment: 137
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: PSA Recurrence
timeFrame: 5-8 months
measure: Change in sexual activity
timeFrame: 5-8 months
Secondary outcomes:
measure: Change in PSA
timeFrame: Baseline to 5-8 months
measure: Clinical Disease Recurrence
timeFrame: 5-8 months
measure: Change in sexual desire
timeFrame: 5-8 months
measure: Change in erectile function
timeFrame: 5-8 months
measure: Change in energy level
timeFrame: 5-8 months
measure: Change in mood
timeFrame: 5-8 months
measure: Change in physical function
timeFrame: 5-8 months
measure: Change in self-reported physical function
timeFrame: 5-8 months
measure: Change in maximal voluntary strength
timeFrame: 5-8 months
measure: Change in lean body mass
timeFrame: 5-8 months
measure: Change in hormone Levels
timeFrame: 5-8 months
measure: Change in aerobic capacity
timeFrame: 5-8 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shalender Bhasin, MD
role: PRINCIPAL_INVESTIGATOR
References: