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NOT YET RECRUITING
NCT07535905
PHASE2

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-07

Completion Date

2030-10

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DRUG

Tamoxifen

Selective estrogen receptor modulator, oral tablet

Locations (1)

University Health Network - Princess Margaret Cancer Center

Toronto, Ontario, Canada