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| Name | Class |
|---|---|
| University of Chicago | OTHER |
| Northwestern University | OTHER |
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The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).
We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. Prostate-specific antigen (PSA) levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Dutasteride During First Off-Cycle | Experimental | Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle |
|
| B: Placebo During First Off-Cycle | Placebo Comparator | Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride | Drug | 0.5 mg capsule given orally on daily basis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle. | Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1. | At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle | Calculation of number of months when baseline PSA doubles compared between the 2 arms at the end of "off-treatment" cycle 1. | At month 9 and ongoing monthly until end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel H Shevrin, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Medical Center | Chicago | Illinois | 60611 | United States | ||
| University of Chicago Hospitals and Clinics |
20 participants enrolled and all received initial treatment with anti-androgen therapy (AAT) for planned 8 months (on-cycle 1). 7 participants progressed during this treatment, so 13 participants proceeded with randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Dutasteride During First Off-Cycle | Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle Dutasteride: 0.5 mg capsule given orally on daily basis |
| FG001 | B: Placebo During First Off-Cycle | Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle Placebo: Identical placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Off-cycle |
|
| |||||||||||||||||||||
| Second AAT Treatment (On-cycle 2) |
| ||||||||||||||||||||||
| Second Off Treatment (Off-cycle 2) |
|
20 participants enrolled to study and received initial AAT treatment for 8 months (on-cycle 1)
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Dutasteride During First Off-Cycle | Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle Dutasteride: 0.5 mg capsule given orally on daily basis |
| BG001 | B: Placebo During First Off-Cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle. | Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1. | Only patients from each arm with biopsies at the end of off-cycle 1 are included. | Posted | Mean | Standard Deviation | Relative expression | At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months) |
|
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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 | A: Dutasteride During First Off-Cycle | Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle Dutasteride: 0.5 mg capsule given orally on daily basis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decrease in libido | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Shevrin | Northshore University Healthsystem | 847-570-2515 | Dshevrin@northshore.org |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Identical placebo |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle Placebo: Identical placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Male participants only | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle Placebo: Identical placebo |
|
|
| Secondary | Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle | Calculation of number of months when baseline PSA doubles compared between the 2 arms at the end of "off-treatment" cycle 1. | Only patients from each arm with biopsies at the end of off-cycle 1 are included. | Posted | Mean | Standard Deviation | Months | At month 9 and ongoing monthly until end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | B: Placebo During First Off-Cycle | Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle Placebo: Identical placebo | 0 | 6 | 0 | 6 | 0 | 6 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |