Prostate Cancer
Conditions
Keywords
prostate, cancer, testosterone replacement, AndroGel, prostatic cancer, prostatic neoplasms
Brief summary
The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.
Detailed description
The primary objective of the study is to determine the effect of testosterone replacement on time to disease progression and time to clinical cancer progression. The secondary objectives are to describe the effect of testosterone replacement on patient-reported quality of life (FACT-P, FACT-fatigue and specific measures from the Expanded Prostate Cancer Index (EPIC): Sexual and Hormonal Assessments), and hand-grip strength; to describe changes in total testosterone, free testosterone, and PSA levels; to explore AR levels in circulating tumor cells as a marker of treatment benefit.
Interventions
DRUGAndroGel
Androgel 1%, 10g daily
DRUGplacebo
placebo
Sponsors
Solvay Pharmaceuticals
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate cancer * Patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy) * Patient was surgically or pharmacologically castrated at least 6 months prior to starting the study * Patient must have had a previous trial of anti-androgen therapy * Patient must have a rising PSA * No evidence of distant metastatic disease * ECOG performance status \< 2 * Age \>18 years * Patients must have normal hepatic function
Exclusion criteria
* Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium) * Patients may not be receiving any other investigational agents * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients receiving renal dialysis * Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded * Patients who have known hypersensitivity to any of the AndroGel ingredients, including testosterone that is chemically synthesized from soy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | Up to 5 years | Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells. | every 8 weeks | The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Androgel Three subjects received testosterone gel
AndroGel: Androgel 1%, 10g daily | 3 |
| Placebo Three subjects received the placebo
Placebo: placebo | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | The study was terminated | 3 | 2 |
Baseline characteristics
| Characteristic | Androgel | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 4.6 | 63.5 years STANDARD_DEVIATION 8.6 | 66.4 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Progression Free Survival
Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.
Time frame: Up to 5 years
Population: This study has been terminated due to poor accrual.
Secondary
To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.
The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.
Time frame: every 8 weeks