HypogonadismPhase 2REVIVENCT07535905
Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients
A Phase 2 study testing Tamoxifen in people with Hypogonadism and Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism, Prostate Cancer
- What is being tested?
- Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- 31 Dec 2026to Oct 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network - Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Alejandro Berlin, MD, 416-946-4501 ext. 5813, alejandro.berlin@uhn.ca
About this study
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
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.
- Conditions
- Hypogonadism, Prostate Cancer
- Being tested
- Tamoxifen
- Medical subject headings
- Hypogonadism, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Selective estrogen receptor modulator, oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Non-Experimental Intervention: Observation | No intervention | Participant will not receive intervention after treatment with ADT. Per routine care, participant will undergo observation for testosterone recovery |
| Experimental Intervention: Tamoxifen | Experimental | 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. Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal Testosterone Recovery
Proportion of participants with normal testosterone levels (i.e. total testosterone > 7.7nmol/L [222 ng/dL])
Measured: 6 months after starting intervention
Secondary outcomes (11)
Disease Control
Measurement of PSA levels in blood
Measured: From enrollment to 2 years after starting treatment
Patient-Reported Toxicities
Collection and assessment of adverse events as per PRO-CTCAE version 6.0
Measured: From enrollment to 2 years after starting treatment
Non-Castrated Testosterone Recovery
Proportion of participants with non-castrated testosterone levels (i.e. 50-222 ng/dL])
Measured: From enrollment to 2 years after starting treatment
Time to Testosterone Recovery
How long it takes for participants to reach non-castrated and normal testosterone levels
Measured: From enrollment to 2 years after starting treatment
Urinary Function (Patient-Reported Quality of Life)
Participant completion of the EPIC-26 questionnaire
Measured: From enrollment to 2 years after starting treatment
Bowel Function (Patient-Reported Quality of Life)
Participant completion of the EPIC-26 questionnaire
Measured: From enrollment to 2 years after starting treatment
Sexual Function (Patient-Reported Quality of Life)
Participant completion of the EPIC-26 questionnaire
Measured: From enrollment to 2 years after starting treatment
Fatigue (Patient-Reported Quality of Life)
Participant completion of the PROMIS-Fatigue Short Form questionnaire
Measured: From enrollment to 2 years after starting treatment
Cognitive Function (Patient-Reported Quality of Life)
Participant completion of the FACT-Cog questionnaire
Measured: From enrollment to 2 years after starting treatment
Depression (Patient-Reported Quality of Life)
Participant completion of the PROMIS Emotional Distress-Depression Short Form questionnaire
Measured: From enrollment to 2 years after starting treatment
Overall Health (Patient-Reported Quality of Life)
Participant completion of the EQ-5D-5L questionnaire
Measured: From enrollment to 2 years after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start31 Dec 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535905
- Sponsor's protocol ID
- 25-5742
- Other IDs
- BERLIN-02
- Acronym
- REVIVE
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No