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Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance

ConditionsProstate CancerHypogonadism, Male
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Testosterone cypionate

    Drug

    Participants will self-inject 100mg of testosterone cypionate once per week for 12 months

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Testosterone cypionateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
Baseline, 12 Months
2

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.

Time frame
Baseline, 12 Months
3

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.

Time frame
Baseline, 12 Months
4

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.

Time frame
Baseline, 12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: