drugset / Trial / NCT03716739
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
Phase 2
Completed
136 enrolled
Dana-Farber Cancer Institute
National Institute on Aging (NIA) · collab
RandomizedParallel-groupDouble-blindSupportive care
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.
Timeline
- Start
- 2019-03-19
- Primary completion
- 2025-05-16
- Completion
- 2025-07-16
Publications
- Bhasin S, Burnett AL, Gagliano-Juca T, Storer TW, Reid KF, Shang YV, Privat F, Chandra MS, Weiss M, Memish-Beleva Y, Lam H, Kibel AS, Pencina KM. Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jul 1;186(7):805-814. doi: 10.1001/jamainternmed.2026.1343.
- Sentana-Lledo D, Saraf A, Morgans AK. Symptom Burden and Survivorship Care for Patients With Prostate Cancer on Androgen Deprivation Therapy. J Natl Compr Canc Netw. 2024 Dec 20;23(1):e247047. doi: 10.6004/jnccn.2024.7047.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Testosterone Cypionate | Small molecule | 100 mg | Intramuscular |