NCT03716739

Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Testosterone Cypionate 100 MG/ML	100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.
DRUG	Placebo	Placebo administered by intramuscular injection weekly for 12 weeks.

Timeline

• Start date: 2019-03-19
• Primary completion: 2025-05-16
• Completion: 2025-07-16
• First posted: 2018-10-23
• Last updated: 2025-09-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study