Back to Search Results- Recruiting
- Treatment
- Interventional
- Non Randomized
- Drug & Other
- PHASE4
- Roswell Park Cancer Institute
- 18 Years -
Study Purpose
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. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.
Intervention
Procedure : Biopsy of Prostate
Procedure : Biospecimen Collection
Procedure : Magnetic Resonance Imaging
Other : Patient Observation
Other : Questionnaire Administration
Drug : Therapeutic Testosterone
Eligibility Requirements
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 procedure
Minimum age: 18
Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer
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 score \> 19
* Family history of venous thromboembolis
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
Recruiting status
Recruiting
Estimated enrollment
600
Study start date
Jan 15, 2025
Study end date
Jan 15, 2029
Last updated
Mar 22, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug & Other
Study phase
PHASE4
Allocation
Non Randomized
Sponsor:
Roswell Park Cancer Institute
Collaborator:
N/A
Investigator:
Ahmed Aly
N/A
Publications
N/A
Websites
N/A
NCT06733350
| Clinic | Location | Investigator | Distance | RECRUITING STATUS | Contact |
|---|