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

Sponsor
University Health Network, Toronto
Study ID
NCT07535905
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamoxifen — DRUG
    Selective estrogen receptor modulator, oral tablet

Study Details

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.

Key Dates

First listed
Apr 17, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Non-Experimental Intervention: Observation
    Participant will not receive intervention after treatment with ADT. Per routine care, participant will undergo observation for testosterone recovery
  • Experimental: Experimental Intervention: Tamoxifen
    Participant will take 2 tamoxifen pills by mouth, every day, for a total of 40 mg each day. The duration of tamoxifen treatment will depend on the duration of the participant's previous ADT treatment. If the participant received ADT treatment for 6 months, they will receive daily Tamoxifen for 3 months. If the participant received ADT treatment for 18-36 months, they will receive daily Tamoxifen for 6 months.

Primary Outcome Measure

Normal Testosterone Recovery [ Time Frame: 6 months after starting intervention ]

Central Contacts

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