Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

NCT ID: NCT03716739

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2025-07-16

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

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Treatment Arm

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

Group Type: ACTIVE_COMPARATOR

Testosterone Cypionate 100 MG/ML

Intervention Type: DRUG

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

Control Arm

Weekly IM administration of placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered by intramuscular injection weekly for 12 weeks.

Interventions

Testosterone Cypionate 100 MG/ML

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

Intervention Type: DRUG

Placebo

Placebo administered by intramuscular injection weekly for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Depo-Testosterone; Inactive comparator

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Shalender Bhasin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shalender Bhasin, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

5R01AG060539-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-733

Identifier Type: -

Identifier Source: org_study_id