Can a cheap breast cancer drug fix hormone recovery in prostate cancer patients?
NCT ID NCT07535905
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether tamoxifen, a drug commonly used for breast cancer, can speed up testosterone recovery in men with prostate cancer who have completed hormone therapy (ADT). Many men experience low testosterone for months or years after stopping ADT, causing fatigue, depression, and other side effects. The trial will enroll 96 men and measure how many regain normal testosterone levels, while also monitoring PSA and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Health Network - Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9, Canada
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Other studies related to the condition(s) this trial covers.
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- A scanner in the operating room could show surgeons exactly where prostate cancer remains