Clinical trial · Interventional
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
NCT07278362CI-TRIAL-00118927not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypogonadism, Male | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Testosterone cypionate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Testosterone cypionate
- description
- Participants will self-inject 100mg of testosterone cypionate once per week for 12 months
- interventionNames
- Drug: Testosterone cypionate
Primary outcomes (1)
- measure
- Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT
- timeFrame
- 12 months
- description
- 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.
Secondary outcomes (8)
- measure
- Mean Change in Serum PSA Levels (ng/mL) from Baseline to 12 Months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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, and had a second confirmatory biopsy within the last 12 months * Males diagnosed with low-risk prostate cancer undergoing active surveillance * Two confirmatory testosterone levels \<300 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 Exclusion Criteria: * 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 * T3 or T4 disease * Uncontrolled cardiovascular disease and sleep apnea * 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
References
Publications (0)
Data not yet available
No reference posted for this study.