| January 28, 2009 |
| March 13, 2009 |
| February 2009 |
| August 2010 (final data collection date for primary outcome measure) |
| To determine if late RTOG greater than and equal to Grade 3 treatment-related morbidity, no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule [ Time Frame: yearly update ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00831623 on ClinicalTrials.gov Archive Site |
| To determine the incidence of acute and late GI and GU morbidity [ Time Frame: yearly update ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer |
| Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-Risk Prostate Cancer |
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. |
| Phase I, Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Prostate Cancer |
- Radiation: Proton Radiation
- Radiation: Proton
|
| |
- 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.
- 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.
- 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.
|
| |
| Recruiting |
| 105 |
| June 2014 |
| August 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Histologically confirmed adenocarcinoma within 180 days of registration
- History & Physical Exam, including DRE, within 8 wks prior to registration
- Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
- Clinical stage T1-T2C
- PSA less than 10 ng.ml within 180 days prior to registration
Exclusion Criteria:
- Prior or concurrent invasive malignancy
- Evidence of distant metastasis
|
| Male |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00831623 |
| Carl J. Rossi, MD, Loma Linda University Dept. of Radiation Medicine |
| 58116 |
| Loma Linda University |
|
| Principal Investigator: |
Carl J Rossi, MD |
Loma Linda University Department of Radiation Medicine |
|
| Study Chair: |
Jerry D Slater, MD |
Loma Linda University Medical Center Dept. of Radiation Medicine |
|
|
| Loma Linda University |
| March 2009 |
