Prostate Cancer
Conditions
Keywords
hypofractionation, proton beam radiation
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONProton 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)
RADIATIONProton
As above
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma within 180 days of registration * History & Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration * Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment * Clinical stage, Tumor Stage (T1-T2C) * Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration
Exclusion criteria
* Prior or concurrent invasive malignancy * Evidence of distant metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer Patients with localized prostate cancer with the following characteristics:
* Histologically confirmed adenocarcinoma within 180 days of registration
* History & Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
* Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
* Clinical stage, Tumor Stage (T1-T2C)
* Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Not 2 years post-treatment | 12 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 76 Participants | — |
| Age, Categorical Between 18 and 65 years | 70 Participants | — |
| Age, Continuous | 65 Years | — |
| PSA | 4.98 ng/mL | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 146 Participants | — |
| Sex/Gender, Customized Male | 146 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 146 |
| other Total, other adverse events | 20 / 146 |
| serious Total, serious adverse events | 1 / 146 |
Outcome results
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.
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Radiation Therapy | Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 | 1 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.
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Radiation Therapy | Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0 | 21 Participants |