Prostate CancerPhase 4NCT07278362
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
A Phase 4 study testing Testosterone cypionate in people with Prostate Cancer and Hypogonadism, Male, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Hypogonadism, Male
- What is being tested?
- Testosterone cypionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2026to 31 May 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Males aged ≥ 18 years old
- Newly diagnosed with low-risk prostate cancer initially confirmed by fusion guided prostate biopsy (transrectal or trans perineal) by multiparametric MRI
- Males diagnosed with low-risk prostate cancer on active surveillance
- Two confirmatory testosterone levels <350 ng/dL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests
- Symptoms of low testosterone (Aging Male's Symptoms Score >27)
- Able to obtain Testosterone medication through insurance or out-of-pocket
- Willing and able to provide written informed consent and able to comply with study requirements
Who cannot join
- Males <18 years old
- History of Testosterone Replacement Therapy (TRT) within the past year.
- Current use of TRT
- Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy
- PSA >10 ng/mL at baseline
- Hematocrit > 51% at baseline
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- T3 or T4 disease
- Unstable angina
- History of breast cancer
- Any other condition or situation which, in the opinion of the investigator, could impact patient safety, prevent successful data collection, or reduce the likelihood of successful study participation
- Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket
- Unable or unwilling to provide informed consent or comply with study requirements
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Desai Sethi Urology Institute
Miami, Florida, 33136
Thomas Masterson
- Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Bruce Kava
About this study
Official title: Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.
- Conditions
- Prostate Cancer, Hypogonadism, Male
- Being tested
- Testosterone cypionate
- Medical subject headings
- Prostatic Neoplasms, Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone cypionateDrug
Participants will self-inject 100mg of testosterone cypionate once per week for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Testosterone cypionate | Experimental | Participants will self-inject 100mg of testosterone cypionate once per week for 12 months Receives: Drug: Testosterone cypionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT
Disease progression is defined as either (1) an increase in prostate cancer grade group on biopsy or (2) conversion from active surveillance to active treatment (e.g., surgery, radiation, or systemic therapy). The proportion of participants who meet either criterion within 12 months of initiating testosterone replacement therapy (TRT) will be reported.
Measured: 12 months
Secondary outcomes (8)
Mean Change in Serum PSA Levels (ng/mL) from Baseline to 12 Months
The mean change in serum PSA levels (ng/mL) will be measured at baseline and 12 months after initiation of TRT. PSA levels will be assessed using a standardized immunoassay. The mean change in PSA level will be used to evaluate clinical outcomes related to TRT.
Measured: Baseline, 12 Months
Change in Total Testosterone Levels (ng/dL) from Baseline to 12 Months
The mean change in serum total testosterone (ng/dL) will be measured at baseline and 12 months after initiation of TRT. Total testosterone levels will be assessed using a standardized immunoassay. The mean change in total testosterone level will be used to evaluate clinical outcomes related to TRT.
Measured: Baseline, 12 Months
Mean Change in Hematocrit Levels (%) from Baseline to 12 Months
The mean change in hematocrit levels (%) will be measured from baseline and 12 months after initiation of TRT. Hematocrit levels will be assessed using a standardized immunoassay. The mean change in hematocrit level will be used to evaluate clinical outcomes related to TRT.
Measured: Baseline, 12 Months
Mean Change in Prostate Volume (mL) as measured by mpMRI from Baseline to 12 Months
The mean change in prostate volume (mL) will be measured at baseline and 12 months after initiation of TRT. Prostate volume will be calculated from T2-weighted mpMRI images using standardized volumetric analysis techniques. The mean change in volume will be used to evaluate clinical outcomes related to TRT.
Measured: Baseline, 12 Months
Mean Change in EPIC-26 Scores from Baseline to 12 Months
Quality of life will be assessed using the EPIC-26 questionnaire at baseline and 12 months. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The mean change in scores will be used to evaluate patient-reported outcomes related to TRT.
Measured: Baseline, 12 Months
Mean Change in SF-12 Scores from Baseline to 12 Months
Quality of life will be assessed using the SF-12 questionnaire at baseline and 12 months. The measure includes items assessing physical and mental functioning and yields two scores for these two components of quality of life. These final scores are norm-based, meaning a score of 50 represents the US population average, with a standard deviation of 10. Scores higher than 50 indicate better health status, while scores lower than 50 suggest worse health status The mean change in scores will be used to evaluate patient-reported outcomes related to TRT.
Measured: Baseline, 12 Months
Mean Change in Aging Male's Symptoms Score (AMS) from Baseline to 12 Months
Quality of life will be assessed using the Aging Male's Symptoms Score (AMS) at baseline and 12 months. Scores range from 17 to 85, with higher scores indicating more severe symptoms. The mean change in scores will be used to evaluate symptom improvement associated with TRT.
Measured: Baseline, 12 Months
Progression-Free Survival (PFS) from Baseline to 5 Years
Elapsed time from treatment initiation until disease progression, conversion to active treatment, or death from any cause. Median PFS, if attained, will also be reported.
Measured: Baseline to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start30 Nov 2026 (estimated)
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce R Kava, University of Miami
- Investigators
- Bruce Kava, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278362
- Sponsor's protocol ID
- 20250346
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
- ClinicalTrials.gov ID
- NCT07278362
- Acronym / sponsor ID
- 20250346
- Conditions
- Prostate Cancer, Hypogonadism, Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone cypionate | Experimental | Drug: Testosterone cypionateParticipants will self-inject 100mg of testosterone cypionate once per week for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males aged ≥ 18 years old
- Newly diagnosed with low-risk prostate cancer initially confirmed by fusion guided prostate biopsy (transrectal or trans perineal) by multiparametric MRI
- Males diagnosed with low-risk prostate cancer on active surveillance
- Two confirmatory testosterone levels <350 ng/dL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests
- Symptoms of low testosterone (Aging Male's Symptoms Score >27)
Key exclusion criteria (12 listed)
- Males <18 years old
- History of Testosterone Replacement Therapy (TRT) within the past year.
- Current use of TRT
- Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy
- PSA >10 ng/mL at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone cypionateParticipants will self-inject 100mg of testosterone cypionate once per week for 12 months | Drug | Testosterone cypionate |
Primary outcome
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT
Time frame: 12 months
Disease progression is defined as either (1) an increase in prostate cancer grade group on biopsy or (2) conversion from active surveillance to active treatment (e.g., surgery, radiation, or systemic therapy). The proportion of participants who meet either criterion within 12 months of initiating testosterone replacement therapy (TRT) will be reported.
8 secondary outcomes
Mean Change in Serum PSA Levels (ng/mL) from Baseline to 12 Months
Time frame: Baseline, 12 Months
Change in Total Testosterone Levels (ng/dL) from Baseline to 12 Months
Time frame: Baseline, 12 Months
Mean Change in Hematocrit Levels (%) from Baseline to 12 Months
Time frame: Baseline, 12 Months
Mean Change in Prostate Volume (mL) as measured by mpMRI from Baseline to 12 Months
Time frame: Baseline, 12 Months
Mean Change in EPIC-26 Scores from Baseline to 12 Months
Time frame: Baseline, 12 Months
Mean Change in SF-12 Scores from Baseline to 12 Months
Time frame: Baseline, 12 Months
Mean Change in Aging Male's Symptoms Score (AMS) from Baseline to 12 Months
Time frame: Baseline, 12 Months
Progression-Free Survival (PFS) from Baseline to 5 Years
Time frame: Baseline to 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruce Kava, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone cypionate in people with Prostate Cancer and Hypogonadism, Male, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce Kava, MD (305-243-6590, bkava@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.