Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

Dana-Farber Cancer Institute136 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

136

Conditions

Prostate Cancer

Interventions

Testosterone Cypionate 100 MG/MLDRUG

100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.

PlaceboDRUG

Placebo administered by intramuscular injection weekly for 12 weeks.

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (3)

Johns Hopkins University

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Participants With Biochemical Recurrence of Prostate Cancer

The primary safety endpoint is the number of participants with biochemical recurrence of prostate cancer. Biochemical recurrence is defined as two or more consecutive serum PSA levels of 0.2 ng/mL or higher.

Time frame: the 12-week treatment and the 3-month follow-up

Change From Baseline in Overall Sexual Activity, Assessed Using Psychosexual Diary Questionnaire (PDQ) Question 4

The primary efficacy endpoint is the change from baseline in overall sexual activity, assessed using Psychosexual Diary Questionnaire (PDQ) Question 4. Subjects complete the PDQ 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 activity (PDQ-4) is assessed using a checklist of 12 sexual activities including sexual interactions, masturbation, intercourse, erection, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for each of the sexual activities. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score ranges from 0 to 12, with 0 indicating no activity had taken place that week and with higher values indicating more sexual activity.

Time frame: Week 6, Week 12

Secondary Outcomes

Change in PSA

The secondary safety endpoint is change in PSA levels. Change from baseline in PSA could not be computed because the majority of the participants had undetectable PSA levels at baseline and post-baseline. Here, the number of participants with various PSA levels is reported.

Time frame: Week 12

Change From Baseline in Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS)

The secondary safety endpoint is the change from baseline in lower urinary tract symptoms, ascertained using the International Prostate Symptom Score (IPSS). The IPSS is a validated 8-question survey (7 symptom questions, 1 quality-of-life question) used to assess the severity of lower urinary tract symptoms (LUTS) associated with BPH, ranging from 0-35, with a higher score indicating a more severe negative symptoms.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.