NCT07535905

Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients

Phase II Controlled Clinical Trial to Test Efficacy and Observe Longitudinal Effects of Tamoxifen for Testosterone Recovery in Medically Castrated Prostate Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tamoxifen	Selective estrogen receptor modulator, oral tablet

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Canada