Prostate Cancer study: Testosterone cypionate
Official title Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
ClinicalTrials.gov ID: NCT07278362
What this study is testing
What is Testosterone cypionate?
Testosterone cypionate is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.