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The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.
Radiation therapy has a long and established role in the curative treatment of organ-confined prostate cancer. However, the optimal radiation dose and treatment schedule remain unknown. The use of hypofractionation has a long and generally successful history in conformal proton beam therapy. Several reports detailing the efficacy and safety of hypofractionated conformal radiation therapy (with x-rays) of prostate cancer can be found in the literature. Hypofractionated conformal proton beam radiation therapy has become our institutional routine for the treatment of numerous solid tumors. The purpose of this study is to determine if a shortened overall treatment schedule will result in equivalent tumor control rates and no increased side effects as compared to our current institutional standard treatment of an equivalent dose given over a longer period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton radiation therapy | Experimental | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiation | Radiation | 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 | To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule. | Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0 | To determine if late CTCAE version 4.0 Grade 2 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule. | Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years |
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Inclusion Criteria:
Exclusion Criteria:
Treatment for prostate cancer in males
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| Name | Affiliation | Role |
|---|---|---|
| Jerry D Slater, MD | Loma Linda University Medical Center Dept. of Radiation Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center / James M. Slater Proton Treatment Center | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16160131 | Background | Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. | |
| 15491710 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Radiation Therapy | Single arm Proton Radiation: 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) Proton: As above |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data
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| ID | Title | Description |
|---|---|---|
| BG000 | Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer | Patients with localized prostate cancer with the following characteristics:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data |
| 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 | Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 | To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule. | Posted | Count of Participants | Participants | Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years |
|
Patients toxicity was assessed at 6 month intervals following completion of treatment through the duration of the trial for a minimum of 2 years, with an average of 5 years.
Acute toxicity was defined as toxicity during treatment and within the three-month post-treatment time point. Late toxicity was defined as toxicity occurring greater than three months post-treatment. Follow-up visits were conducted every three months for the first two years after treatment, every six months for the next three years, and annually thereafter. During follow-up visits history and physical exam were performed, PSA was measured, and toxicity was evaluated.
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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 | Proton Radiation Therapy | Single arm Proton Radiation: 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) Proton: As above |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment | Gross hematuria in a patient with a long history of nephrolithiasis, and had nephrolithiasis found on cystoscopy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 2 Gastrointestinal toxicity | Gastrointestinal disorders | Non-systematic Assessment | incidence of grade 2 gastrointestinal toxicity was 4% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Slater | LomaLindaU | 909-558-4243 | jaslater@llu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2014 | May 18, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 5, 2015 | May 18, 2021 | ICF_001.pdf |
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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 |
|---|---|
| D061766 | Proton Therapy |
| D011522 | Protons |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D002414 | Cations, Monovalent |
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| Proton | Radiation | As above |
|
|
| Rossi CJ Jr, Slater JD, Yonemoto LT, Jabola BR, Bush DA, Levy RP, Grove R, Slater JM. Influence of patient age on biochemical freedom from disease in patients undergoing conformal proton radiotherapy of organ-confined prostate cancer. Urology. 2004 Oct;64(4):729-32. doi: 10.1016/j.urology.2004.04.043. |
| 15145147 | Background | Slater JD, Rossi CJ Jr, Yonemoto LT, Bush DA, Jabola BR, Levy RP, Grove RI, Preston W, Slater JM. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):348-52. doi: 10.1016/j.ijrobp.2003.10.011. |
| 24066950 | Background | Slater JM, Bush DA, Grove R, Slater JD. The prognostic value of percentage of positive biopsy cores, percentage of cancer volume, and maximum involvement of biopsy cores in prostate cancer patients receiving proton and photon beam therapy. Technol Cancer Res Treat. 2014 Jun;13(3):227-31. doi: 10.7785/tcrtexpress.2013.600271. Epub 2013 Sep 20. |
| 20932675 | Background | Coen JJ, Bae K, Zietman AL, Patel B, Shipley WU, Slater JD, Rossi CJ. Acute and late toxicity after dose escalation to 82 GyE using conformal proton radiation for localized prostate cancer: initial report of American College of Radiology Phase II study 03-12. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1005-9. doi: 10.1016/j.ijrobp.2010.06.047. Epub 2010 Oct 6. |
| 20233822 | Background | Talcott JA, Rossi C, Shipley WU, Clark JA, Slater JD, Niemierko A, Zietman AL. Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer. JAMA. 2010 Mar 17;303(11):1046-53. doi: 10.1001/jama.2010.287. |
| 20124169 | Background | Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol. 2010 Mar 1;28(7):1106-11. doi: 10.1200/JCO.2009.25.8475. Epub 2010 Feb 1. |
| 16551128 | Background | Slater JD. Clinical applications of proton radiation treatment at Loma Linda University: review of a fifteen-year experience. Technol Cancer Res Treat. 2006 Apr;5(2):81-9. doi: 10.1177/153303460600500202. |
| 16488552 | Background | Ronson BB, Yonemoto LT, Rossi CJ, Slater JM, Slater JD. Patient tolerance of rectal balloons in conformal radiation treatment of prostate cancer. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1367-70. doi: 10.1016/j.ijrobp.2005.11.001. Epub 2006 Feb 20. |
| 10223493 | Background | Slater JD, Rossi CJ Jr, Yonemoto LT, Reyes-Molyneux NJ, Bush DA, Antoine JE, Miller DW, Teichman SL, Slater JM. Conformal proton therapy for early-stage prostate cancer. Urology. 1999 May;53(5):978-84. doi: 10.1016/s0090-4295(99)00014-x. |
| 9788407 | Background | Slater JD, Yonemoto LT, Rossi CJ Jr, Reyes-Molyneux NJ, Bush DA, Antoine JE, Loredo LN, Schulte RW, Teichman SL, Slater JM. Conformal proton therapy for prostate carcinoma. Int J Radiat Oncol Biol Phys. 1998 Sep 1;42(2):299-304. doi: 10.1016/s0360-3016(98)00225-9. |
| Background | Slater JD. Twenty years of proton radiation therapy at Loma Linda University Medical Center. In U. Linz, editor. Ion beam therapy: fundamentals, technology, clinical applications. Berlin: Springer, 2012:581-595. |
| 31773043 | Result | Slater JM, Slater JD, Kang JI, Namihas IC, Jabola BR, Brown K, Grove R, Watt C, Bush DA. Hypofractionated Proton Therapy in Early Prostate Cancer: Results of a Phase I/II Trial at Loma Linda University. Int J Part Ther. 2019 Summer;6(1):1-9. doi: 10.14338/IJPT-19-00057. Epub 2019 Aug 6. |
| Count of Participants |
| Participants |
|
| Age, Continuous | 8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data | Median | Full Range | Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| PSA | Median | Full Range | ng/mL |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0 | To determine if late CTCAE version 4.0 Grade 2 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule. | Posted | Count of Participants | Participants | Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years |
|
|
|
| 0 |
| 146 |
| 1 |
| 146 |
| 20 |
| 146 |
|
|
| Grade 2 Genitourinary toxicity | Renal and urinary disorders | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002412 |
| Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |