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The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer.
Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Alone | Active Comparator | Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy |
|
| Radiation + Androgen Suppression | Experimental | Androgen Suppression Therapy x 6 months + Radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Consists of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity Outcomes | To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression. Freedom from failure (FFF): 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) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression | after the initial 100 patients have had a median follow up of at least three years and then every year. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of grade 2 or higher GU and GI toxicity | Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria | At 6 months |
| Frequency and severity of GI and GU toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Vargas, MD | Proton Collaborative Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Scottsdale | Arizona | 85259-5499 | United States |
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|
| Androgen Suppression Therapy | Drug | Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions) |
|
|
| At 3 years |
| Incidence of quality of life issues | At completion of radiation therapy |
| Incidence of Freedom from biochemical failure (FFBF) | At 5 years |
| Incidence of clinical failure: local and/or distant | At 5 years |
| Incidence of salvage Androgen Suppression use (SAD) | At 5 years |
| Incidence of progression free survival: using clinical, biochemical and SAD as events | At 5 years |
| Incidence of overall survival | At 5 years |
| Incidence of disease-specific survival | At 5 years |
| Correlate pathologic and radiologic findings with outcomes | At 5 years |
| Correlate PSA and free PSA levels with outcomes | At 5 years |
| Correlate testosterone levels and variation with proton therapy and outcomes | At 5 years |
| Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity | At 3 years |
| Northwestern Medicine Chicago Proton Center | Recruiting | Warrenville | Illinois | 60555 | United States |
|
| Oklahoma Proton Center | Recruiting | Oklahoma City | Oklahoma | 73142 | United States |
|
| Hampton University Proton Therapy Institute | Recruiting | Hampton | Virginia | 23666 | United States |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D016729 | Leuprolide |
| D017273 | Goserelin |
| D002064 | Buserelin |
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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