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The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Radiation Hypofractionation | Other | 5 fractions (7.6 Gy(RBE) x 5) |
|
| Proton Radiation Standard Fractionation | Active Comparator | 44 fractions (1.8 Gy(RBE) x 44) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiation Hypofractionation | Radiation | Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy. | The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA),or the start of salvage therapy including androgen deprivation. | At 5 years post treatment completion +/- 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens. | At 6 months and 2 years post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Vargas, MD | Proton Collaborative Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Cancer Center | Phoenix | Arizona | 85054 | United States | ||
| Northwestern Medicine Chicago Proton Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38972465 | Derived | Toesca DAS, Hartsell WF, DeWees TA, Chang JH, Laughlin BS, Voss MM, Dodoo CA, Mohammed N, Keole SR, McGee LA, Gondi V, Sweeney PJ, Dorn P, Sinesi CC, Doh LS, Rich T, Vargas CE. Stereotactic Body Proton Therapy Versus Conventionally Fractionated Proton Therapy for Early Prostate Cancer: A Randomized, Controlled, Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2024 Dec 1;120(5):1377-1385. doi: 10.1016/j.ijrobp.2024.05.014. Epub 2024 Jul 6. |
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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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| Proton Radiation Standard Fractionation | Radiation | Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks |
|
|
| Warrenville |
| Illinois |
| 60555 |
| United States |
| Maryland Proton Treatment Center | Baltimore | Maryland | 21201 | United States |
| Oklahoma Proton Center | Oklahoma City | Oklahoma | 73142 | United States |
| Hampton University Proton Therapy Institute | Hampton | Virginia | 23666 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |