Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
NCT ID: NCT06733350
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
600 participants
INTERVENTIONAL
2025-01-15
2029-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
NCT00006044
Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer
NCT01326312
A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer
NCT01084759
Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer
NCT06305598
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT03678025
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To investigate the impact of TRT on Gleason grade progression in hypogonadal men with localized prostate cancer on active surveillance, and the association between TRT and the likelihood of discontinuation of active surveillance in the same population.
II. To assess the impact of TRT on the quality of life, including changes in the International Prostate Symptom Score (IPSS) and the association with sexual health measured by the Sexual Health Inventory for Men (SHIM), in hypogonadal men with localized prostate cancer on active surveillance.
SECONDARY OBJECTIVES:
I. To examine the influence of TRT on radiographic progression in hypogonadal men with localized prostate cancer on active surveillance, by assessing changes in the size of abnormal magnetic resonance imaging (MRI) lesions.
II. To evaluate the association between TRT and biochemical progression by analyzing changes in prostate-specific antigen (PSA) levels over time in the studied population.
III. To systematically monitor and document TRT-related adverse events and complications, and concurrently assess the association between TRT and the likelihood of discontinuation due to adverse events in the studied population.
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP 1: Patients with normal testosterone level undergo standard AS for up to 5 years in the absence of disease progression. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.
GROUP 2: Patients with low testosterone level associated with hypogonadal symptoms and willing to receive TRT receive testosterone per treating physician discretion via injection, gel, lotion, or transdermal patch and undergo standard AS for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.
GROUP 3: Patients with low testosterone level with no symptoms, or low testosterone level associated with hypogonadal symptoms but declined TRT undergo standard AS for up to 5 years in the absence of disease progression. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 (AS)
Patients with normal testosterone level undergo standard AS for up to 5 years in the absence of disease progression. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.
Biopsy of Prostate
Undergo prostate biopsy
Biospecimen Collection
Undergo blood sample collection
Magnetic Resonance Imaging
Undergo MRI
Patient Observation
Undergo standard AS
Questionnaire Administration
Ancillary studies
Group 2 (TRT, AS)
Patients with low testosterone level associated with hypogonadal symptoms and willing to receive TRT receive testosterone per treating physician discretion via injection, gel, lotion, or transdermal patch and undergo standard AS for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.
Biopsy of Prostate
Undergo prostate biopsy
Biospecimen Collection
Undergo blood sample collection
Magnetic Resonance Imaging
Undergo MRI
Patient Observation
Undergo standard AS
Questionnaire Administration
Ancillary studies
Therapeutic Testosterone
Given via injection, gel, lotion, or transdermal patch
Group 3 (AS)
Patients with low testosterone level with no symptoms, or low testosterone level associated with hypogonadal symptoms but declined TRT undergo standard AS for up to 5 years in the absence of disease progression. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.
Biopsy of Prostate
Undergo prostate biopsy
Biospecimen Collection
Undergo blood sample collection
Magnetic Resonance Imaging
Undergo MRI
Patient Observation
Undergo standard AS
Questionnaire Administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biopsy of Prostate
Undergo prostate biopsy
Biospecimen Collection
Undergo blood sample collection
Magnetic Resonance Imaging
Undergo MRI
Patient Observation
Undergo standard AS
Questionnaire Administration
Ancillary studies
Therapeutic Testosterone
Given via injection, gel, lotion, or transdermal patch
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Roswell Park Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed Aly
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2024-09551
Identifier Type: REGISTRY
Identifier Source: secondary_id
I-3920923
Identifier Type: OTHER
Identifier Source: secondary_id
I-3920923
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.