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.
At least 18 years of age;
Ability to understand the purposes and risks of the trial and has signed a written informed consent form. Have a diagnosis of prostate cancer;
Patient received ADT for a duration of either 6 or 18-36 months as part of the curative intent treatment. Curative intent prostate cancer patients who completed ADT and have had no further ADT for the length of the last ADT injection depot formulation (e.g., if the last ADT injection depot formulation is for 3 months, the patient must have no ADT for 3 months after last injection)
Have effectively castrated testosterone (< 1.7 nmol/L [50 ng/dL]) within 6 weeks of enrollment;
Harbouring certain CYP2D6 alleles (i.e. CYP2D6*4) or from the chronic use of a CYP2D6 inhibitor(s);
History of blood clots (venous thromboembolism or pulmonary embolism);
History of stroke or transient ischemic attack (TIA);
Total Bilirubin: 1.5 > upper limit of normal (ULN) (For Gilbert's syndrome, if total bilirubin is <1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is greater than 1.5 x ULN, participant is ineligible;
Parallel
Tamoxifen
DrugSelective estrogen receptor modulator, oral tablet
Normal Testosterone Recovery
Proportion of participants with normal testosterone levels (i.e. total testosterone \> 7.7nmol/L \[222 ng/dL\])
Disease Control
Measurement of PSA levels in blood
Patient-Reported Toxicities
Collection and assessment of adverse events as per PRO-CTCAE version 6.0
Non-Castrated Testosterone Recovery
Proportion of participants with non-castrated testosterone levels (i.e. 50-222 ng/dL\])
Time to Testosterone Recovery
How long it takes for participants to reach non-castrated and normal testosterone levels
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This trial is not recruiting at the moment. You can still explore other options:
