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Can a cheap breast cancer drug fix hormone recovery in prostate cancer patients?

NCT ID NCT07535905

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University Health Network - Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9, Canada

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