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The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDR brachytherapy - 21 Gy | Experimental | -All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy. |
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| HDR brachytherapy - 23 Gy | Experimental | -All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy. |
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| HDR brachytherapy - 25 Gy | Experimental | -All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDR brachytherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical control experienced by patients with prostate cancer treated with an HDR implant | -Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng/mL or more above the PSA nadir | Through 3 years after implant |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. | From start of treatment through 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal dose of radiation | -The optimal dose is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity within the DLT assessment period (3 months after implant) OR the maximally administered dose if fewer than 2 patients in that cohort experience DLT. | Through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiram A Gay, M.D. | Contact | 314-362-8516 | hiramgay@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hiram A Gay, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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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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|
| Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant |
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| From day 91 through 3 years after implant |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |