Bladder Cancer, Low Testosterone Levels
Conditions
Keywords
radical cystectomy, hypogonadism
Brief summary
The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.
Interventions
None listed
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bladder cancer * Scheduled to undergo radical cystectomy
Exclusion criteria
* Evidence of advanced metastatic disease, * Undergoing cystectomy for non-bladder primary malignancy or bladder cancer type other than urothelial cell * History of breast or prostate cancer * Polycythemia, cardiovascular thromboembolism, untreated obstructive sleep apnea, uncontrolled heart failure, or acute coronary event in the past six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical | 90 days post-RC surgery | The count of participants with hypogonadism (the level of serum testosterone used as a threshold). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy | 30 days post-RC surgery | The count of participants with hypogonadism 30 days post radical cystectomy using the serum testosterone levels (the level of serum testosterone used as a threshold). |
| The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy | Immediately post-operatively RC surgery | The count of participants with hypogonadism immediately post radical cystectomy based on levels of testosterone (the level of serum testosterone used as a threshold). |
| The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy | Baseline, prior to RC surgery | The count of participants with hypogonadism at baseline days post radical cystectomy (the level of serum testosterone used as a threshold). |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from University of Kansas Medical Center Urology Clinics
Participants by arm
| Arm | Count |
|---|---|
| Bladder Cancer Patients Patients with bladder cancer scheduled to undergo radical cystectomy (RC). | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Bladder Cancer Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 68.9 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical
The count of participants with hypogonadism (the level of serum testosterone used as a threshold).
Time frame: 90 days post-RC surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bladder Cancer Patients | Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical | 6 participants |
Secondary
The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy
The count of participants with hypogonadism 30 days post radical cystectomy using the serum testosterone levels (the level of serum testosterone used as a threshold).
Time frame: 30 days post-RC surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bladder Cancer Patients | The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy | 8 Participants |
Secondary
The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy
The count of participants with hypogonadism at baseline days post radical cystectomy (the level of serum testosterone used as a threshold).
Time frame: Baseline, prior to RC surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bladder Cancer Patients | The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy | 12 Participants |
Secondary
The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy
The count of participants with hypogonadism immediately post radical cystectomy based on levels of testosterone (the level of serum testosterone used as a threshold).
Time frame: Immediately post-operatively RC surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bladder Cancer Patients | The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy | 19 Participants |