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This study has been terminated due to poor accrual
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| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Twenty subjects will receive testosterone gel |
|
| B | Placebo Comparator | Twenty subjects will receive the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AndroGel | Drug | Androgel 1%, 10g daily |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Stadler, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22939385 | Derived | Geynisman DM, Szmulewitz RZ, Stadler WM. A trial postmortem: challenges in conducting a randomized, double-blind, phase 2 study in men with castration-resistant prostate cancer. Eur Urol. 2012 Nov;62(5):864-6. doi: 10.1016/j.eururo.2012.08.030. Epub 2012 Aug 25. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Androgel | Three subjects received testosterone gel AndroGel: Androgel 1%, 10g daily |
| FG001 | Placebo | Three subjects received the placebo Placebo: placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
placebo |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Northwestern University | Chicago | Illinois | 60610 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| NorthShore University Helath System | Evnaston | Illinois | 60201 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61656 | United States |
| University of Maryland | Baltimore | Maryland | 21202 | United States |
| University of Rochester | Rochester | Maryland | 14642 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Androgel | Three subjects received testosterone gel AndroGel: Androgel 1%, 10g daily |
| BG001 | Placebo | Three subjects received the placebo Placebo: placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This study has been terminated due to poor accrual. | Posted | Up to 5 years |
|
| ||||||||||||||||||||||
| 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. | Posted | every 8 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Androgel | Three subjects received testosterone gel AndroGel: Androgel 1%, 10g daily | 0 | 3 | 3 | 3 | ||
| EG001 | Placebo | Three subjects received the placebo Placebo: placebo | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| |||
| Alkaline phosphatase increased | Investigations |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Blood bicarbonate decreased | Investigations |
| |||
| Coarse hair | Skin and subcutaneous tissue disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Dark stools | Gastrointestinal disorders |
| |||
| Erectile dysfunction | Reproductive system and breast disorders |
| |||
| Fatigue | General disorders |
| |||
| Hemoglobin | Investigations |
| |||
| Hemoglobin decreased | Investigations |
| |||
| Hemorrhage urinary tract | Renal and urinary disorders |
| |||
| Hyperglycemia | Investigations |
| |||
| Hyperkalemia | Investigations |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypophosphatemia | Investigations |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Joint pain | Musculoskeletal and connective tissue disorders |
| |||
| Libido decreased | Psychiatric disorders |
| |||
| Lymphopenia | Investigations |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Pain- other: shoulder and back pain | General disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Peripheral sensory neuropathy | Nervous system disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Urinary frequency | Renal and urinary disorders |
| |||
| Urogenital disorder | Renal and urinary disorders |
| |||
| Vomiting | Gastrointestinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Walter Stadler | The University of Chicago | 773-702-4400 | wstadler@medicine.bsd.uchicago.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Male |
|