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

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

Overview

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.

Interventions

• Drug Tamoxifen
  Selective estrogen receptor modulator, oral tablet

Primary outcome measures

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

Secondary outcome measures (11)

• Disease Control [Time frame: From enrollment to 2 years after starting treatment]
• Patient-Reported Toxicities [Time frame: From enrollment to 2 years after starting treatment]
• Non-Castrated Testosterone Recovery [Time frame: From enrollment to 2 years after starting treatment]
• Time to Testosterone Recovery [Time frame: From enrollment to 2 years after starting treatment]
• Urinary Function (Patient-Reported Quality of Life) [Time frame: From enrollment to 2 years after starting treatment]
• Bowel Function (Patient-Reported Quality of Life) [Time frame: From enrollment to 2 years after starting treatment]
• Sexual Function (Patient-Reported Quality of Life) [Time frame: From enrollment to 2 years after starting treatment]
• Fatigue (Patient-Reported Quality of Life) [Time frame: From enrollment to 2 years after starting treatment]
• Cognitive Function (Patient-Reported Quality of Life) [Time frame: From enrollment to 2 years after starting treatment]
• Depression (Patient-Reported Quality of Life) [Time frame: From enrollment to 2 years after starting treatment]
• Overall Health (Patient-Reported Quality of Life) [Time frame: From enrollment to 2 years after starting treatment]

Eligibility criteria

Inclusion criteria

• 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;
• ECOG Performance status 0-2

Exclusion criteria

• 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);
• Reduced liver function within last 120 days prior to enrolment, defined as follows:

• 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;
• AST(SGOT) and ALT(SGPT): > 2.5x ULN;
• Or other liver disease as deemed ineligible by the investigator
• Baseline QT/QTc > 500ms;
• Active therapy with selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g. paroxetine, a known CYP2D6 inhibitor);
• Active therapy with coumarin-type anticoagulants;
• Active therapy with cytotoxic agents;
• Active therapy with aromatase inhibitors;
• Other invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin;
• Treatment with a non-approved or experimental drug during the 3 months before informed consent;
• Patients known to have one of the following hereditary illnesses; galactose- intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
• Any other significant concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this trial;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• University Health Network - Princess Margaret Cancer Center — Toronto

Identifiers

NCT: NCT07535905 · 25-5742

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗