Tamoxifen to speed testosterone recovery after ADT in men with prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 2 trial examines whether tamoxifen can accelerate testosterone recovery in men with prostate cancer who have completed androgen deprivation therapy. Eligible participants are adults with castrated testosterone levels who have finished ADT for curative treatment and meet specific health criteria. The study will monitor testosterone levels, safety, and tolerability during tamoxifen treatment. Results could indicate a cost-effective option to reduce hypogonadal symptoms after ADT, especially in settings with limited resources.

Why it matters

Who can join: the full rules

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:

  1. 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;
  2. AST(SGOT) and ALT(SGPT): \> 2.5x ULN;
  3. 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;

Where it's running

• University Health Network - Princess Margaret Cancer Center
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Alejandro Berlin, MD
• Email: alejandro.berlin@uhn.ca
• Phone: 416-946-4501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.