Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients
NCT07535905 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2026-04-17
Summary
Androgen deprivation therapy (ADT) is a cornerstone therapy in the treatment of curable prostate cancer (PCa). However, ADT often leads to a protracted testosterone recovery period in most men or absence of complete recovery in 10-25% of cases. The hypogonadal state has significant psychosocial and physical side effects. Therefore, limiting ADT effect's duration beyond the prescribed castration period is very compelling to patients and providers alike.
Tamoxifen, a well-established selective estrogen receptor modulator, offers a novel and cost-effective approach to accelerate testosterone recovery in men with secondary hypogonadism. This project addresses a critical gap in global cancer care by evaluating Tamoxifen as a viable solution for reducing the burden of delayed testosterone recovery and its associated side effects, particularly in resource-limited settings.
Conditions
- Hypogonadism
- Prostate Cancer
Interventions
- DRUG
-
Tamoxifen
Selective estrogen receptor modulator, oral tablet
Sponsors & Collaborators
-
University Health Network, Toronto
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2030-10-31
- Completion
- 2030-10-31
Countries
- Canada
Study Locations
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