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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Selective estrogen receptor modulator, oral tablet
University Health Network - Princess Margaret Cancer Center
Toronto, Ontario, Canada
Normal Testosterone Recovery
Proportion of participants with normal testosterone levels (i.e. total testosterone \> 7.7nmol/L \[222 ng/dL\])
Time frame: 6 months after starting intervention
Disease Control
Measurement of PSA levels in blood
Time frame: From enrollment to 2 years after starting treatment
Patient-Reported Toxicities
Collection and assessment of adverse events as per PRO-CTCAE version 6.0
Time frame: From enrollment to 2 years after starting treatment
Non-Castrated Testosterone Recovery
Proportion of participants with non-castrated testosterone levels (i.e. 50-222 ng/dL\])
Time frame: From enrollment to 2 years after starting treatment
Time to Testosterone Recovery
How long it takes for participants to reach non-castrated and normal testosterone levels
Time frame: From enrollment to 2 years after starting treatment
Urinary Function (Patient-Reported Quality of Life)
Participant completion of the EPIC-26 questionnaire
Time frame: From enrollment to 2 years after starting treatment
Bowel Function (Patient-Reported Quality of Life)
Participant completion of the EPIC-26 questionnaire
Time frame: From enrollment to 2 years after starting treatment
Sexual Function (Patient-Reported Quality of Life)
Participant completion of the EPIC-26 questionnaire
Time frame: From enrollment to 2 years after starting treatment
Fatigue (Patient-Reported Quality of Life)
Participant completion of the PROMIS-Fatigue Short Form questionnaire
Time frame: From enrollment to 2 years after starting treatment
Cognitive Function (Patient-Reported Quality of Life)
Participant completion of the FACT-Cog questionnaire
Time frame: From enrollment to 2 years after starting treatment
Depression (Patient-Reported Quality of Life)
Participant completion of the PROMIS Emotional Distress-Depression Short Form questionnaire
Time frame: From enrollment to 2 years after starting treatment
Overall Health (Patient-Reported Quality of Life)
Participant completion of the EQ-5D-5L questionnaire
Time frame: From enrollment to 2 years after starting treatment
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