An interventional study of Proton Radiation and Proton in Prostate Cancer, sponsored by Loma Linda University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 167 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm
Radiation: Proton Radiation · Radiation: Proton
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)
As above
Also known as: Proton Radiation treatment
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.
Time frame: 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
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.
Time frame: 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
| Milestone | Proton Radiation Therapy |
|---|---|
| Started | 167 |
| Treated per protocol | 158 |
| At least 2 years since completing treatment | 146 |
| Completed | 145 |
| Not completed | 22 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Not 2 years post-treatment | 12 |
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.
| Participants | Proton Radiation Therapy |
|---|---|
| Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 | 1 |
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.
| Participants | Proton Radiation Therapy |
|---|---|
| Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0 | 21 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proton Radiation Therapy | 0/146 (0%) | 1/146 (0.7%) | 20/146 (13.7%) |
| Event | Proton Radiation Therapy |
|---|---|
| HematuriaRenal and urinary disorders | 1/146 |
| Event | Proton Radiation Therapy |
|---|---|
| Grade 2 Genitourinary toxicityRenal and urinary disorders | 13/146 |
| Grade 2 Gastrointestinal toxicityGastrointestinal disorders | 7/146 |
8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data
| Age, Categorical(Participants) | Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 70 |
| >=65 years | 76 |
| Age, Continuous(Years) | Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer |
|---|---|
| Median | 65 (33 to 80) |
| Sex/Gender, Customized(Participants) | Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer |
|---|---|
| Male | 146 |
| Race and Ethnicity Not Collected(Participants) | Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer |
|---|
| Region of Enrollment(Participants) | Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer |
|---|---|
| United States | 146 |
| PSA(ng/mL) | Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer |
|---|---|
| Median | 4.98 (0.3 to 10.2) |
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