drugset / Trial / NCT07535905

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

NCT07535905

Phase 2 Not yet recruiting 96 enrolled University Health Network, Toronto
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-07
Primary completion
2030-10
Completion
2030-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamoxifen Small molecule 40 mg Oral