Tamoxifen for Testosterone Recovery in Prostate Cancer

(REVIVE Trial)

Overseen By Alejandro Berlin, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must not be taking: SSRIs, Coumarins, Cytotoxics, Aromatase inhibitors

Disqualifiers: Blood clots, Stroke, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I understand the trial and have signed the consent form.

I finished ADT and have not had more ADT since my last injection wore off.

My testosterone level is very low, below 50 ng/dL, within the last 6 weeks.

Exclusion Criteria

Treatment with a non-approved or experimental drug during the 3 months before informed consent

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

I have had another invasive cancer in the past 5 years, except for certain skin cancers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tamoxifen treatment to accelerate testosterone recovery

3-6 months

Monthly visits for monitoring

Follow-up

Participants are monitored for testosterone recovery and disease control

2 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Tamoxifen

How Is the Trial Designed?

Group I: Experimental Intervention: Tamoxifen Experimental Treatment 1 Intervention

Participant will take 2 tamoxifen pills by mouth, every day, for a total of 40 mg each day. The duration of tamoxifen treatment will depend on the duration of the participant's previous ADT treatment. If the participant received ADT treatment for 6 months, they will receive daily Tamoxifen for 3 months. If the participant received ADT treatment for 18-36 months, they will receive daily Tamoxifen for 6 months.

Group II: Non-Experimental Intervention: Observation Active Control 1 Intervention

Participant will not receive intervention after treatment with ADT. Per routine care, participant will undergo observation for testosterone recovery

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+