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New treatment option for Localized Prostate Carcinoma
Official title Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
ClinicalTrials.gov ID: NCT06733350
What this study is testing
What is Therapeutic Testosterone?
Therapeutic Testosterone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for localized prostate carcinoma.
Also referred to as Mertestate, Testoderm.
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
- This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results.
- Phase 4: studies an already-approved treatment
- Time commitment: about 5 years
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
- Men aged ≥ 18 years
- Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network [NCCN] very low, low, and intermediate...
- Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved...
You likely can't join if
- Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer
- For men being considered for Group 2 (TRT), Patients with contraindications to TRT, which include,
- Locally advanced or metastatic prostate cancer
- Male breast cancer
- Men with an active desire to have children
- Hematocrit levels \> 54% or baseline hematocrit of 48-50%
See the full eligibility criteria
- Men aged ≥ 18 years
- Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network [NCCN] very low, low, and intermediate favorable risk group)
- Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related...
- Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer
- For men being considered for Group 2 (TRT), Patients with contraindications to TRT, which include,
- Locally advanced or metastatic prostate cancer
- Male breast cancer
- Men with an active desire to have children
- Hematocrit levels \> 54% or baseline hematocrit of 48-50%
- Uncontrolled or poorly controlled congestive heart failure
- IPSS (International Prostate Symptom Score) score \> 19
- Family history of venous thromboembolism
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.