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The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).
Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ePURT 5Gy x 5 fractions with single HDR boost of 15Gy | Experimental | Single arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePURT 5Gy x 5 fractions with single HDR boost of 15Gy | Radiation | ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with acute grade ≥ 2 GU toxicity | Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with acute grade ≥ 2 GI toxicity | Acute grade ≥ 2 GI toxicity at 3 months post ePUHRT with HDR boost by CTCAE version 5 | 3 months |
| Percentage of participants with acute grade ≥ 2 GU toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar Ishaq, MD | Contact | 317-944-2524 | oishaq@iuhealth.org | |
| Kathy Lauer, BA | Contact | 317-962-3172 | KLauer@iuhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Omar Ishaq, MD | Indiana University Simon Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
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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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Self-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by PRO-CTCAE
| 3 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |