Prostate Cancer
Conditions
Keywords
CaP, SBRT, Prostate, ExacTrac, Calypso, IMRT, Radiation, Cancer of Prostate, Prostatic Neoplasms
Brief summary
The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.
Detailed description
This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.
Interventions
RADIATIONSBRT Prostate
Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment * History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment * Gleason score less than or equal to 7 * Clinical Stage T1-T2c * PSA * less than or = 15 ng/ml prior to start of therapy if Gleason \< or = 6 or * less than or = 10 ng/ml prior to start of therapy if Gleason = 7 * Zubrod Performance Status 0-1 * Age \> 40
Exclusion criteria
* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible) * Evidence of distant metastases * Regional lymph node involvement * Significant urinary obstruction * Estimated prostate gland \> 100 grams * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy * Previous or concurrent cytotoxic chemotherapy for prostate cancer * Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip). * Severe, active comorbidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Genitourinary Acute Toxicity | </= 90 days post radiation treatment, a total of 90 days | Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment |
| Number of Participants With Genitourinary Late Toxicity | >90 days from the end of treatment, up to 3 years | Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment |
| Number of Participants With Gastrointestinal Acute Toxicity | </= 90 days post radiation treatment, a total of 90 days | Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment |
| Number of Participants With Gastrointestinal Late Toxicity | >90 days from the end of treatment, up to 3 years | Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form | 3 years post-treatment | The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life. |
| Disease Free Survival | 5 yrs | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stereotactic Radiotherapy Five fractions of 7.4 Gy each
SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Stereotactic Radiotherapy |
|---|---|
| Age, Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 60 |
| other Total, other adverse events | 51 / 60 |
| serious Total, serious adverse events | 1 / 60 |
Outcome results
Primary
Number of Participants With Gastrointestinal Acute Toxicity
Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
Time frame: </= 90 days post radiation treatment, a total of 90 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Acute Toxicity | Grade 1 | 19 Participants |
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Acute Toxicity | Grade 2 | 3 Participants |
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Acute Toxicity | Grade 3 | 0 Participants |
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Acute Toxicity | Grade 4 | 0 Participants |
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Acute Toxicity | Grade 5 | 0 Participants |
Primary
Number of Participants With Gastrointestinal Late Toxicity
Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment
Time frame: >90 days from the end of treatment, up to 3 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Late Toxicity | Grade 1 | 15 Participants |
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Late Toxicity | Grade 2 | 5 Participants |
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Late Toxicity | Grade 3 | 1 Participants |
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Late Toxicity | Grade 4 | 0 Participants |
| Stereotactic Radiotherapy | Number of Participants With Gastrointestinal Late Toxicity | Grade 5 | 0 Participants |
Primary
Number of Participants With Genitourinary Acute Toxicity
Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
Time frame: </= 90 days post radiation treatment, a total of 90 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Acute Toxicity | Grade 1 | 44 Participants |
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Acute Toxicity | Grade 2 | 15 Participants |
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Acute Toxicity | Grade 3 | 0 Participants |
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Acute Toxicity | Grade 4 | 0 Participants |
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Acute Toxicity | Grade 5 | 0 Participants |
Primary
Number of Participants With Genitourinary Late Toxicity
Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment
Time frame: >90 days from the end of treatment, up to 3 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Late Toxicity | Grade 3 | 0 Participants |
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Late Toxicity | Grade 4 | 0 Participants |
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Late Toxicity | Grade 1 | 22 Participants |
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Late Toxicity | Grade 2 | 4 Participants |
| Stereotactic Radiotherapy | Number of Participants With Genitourinary Late Toxicity | Grade 5 | 0 Participants |
Secondary
Disease Free Survival
Time frame: 5 yrs
Population: Data not collected.
Secondary
Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form
The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.
Time frame: 3 years post-treatment
Population: Only participants who provided responses for each domain were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stereotactic Radiotherapy | Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form | Urinary Domain | 94.1 score on a scale | Standard Deviation 14.7 |
| Stereotactic Radiotherapy | Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form | Sexual Domain | 77.7 score on a scale | Standard Deviation 27.6 |
| Stereotactic Radiotherapy | Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form | Bowel Domain | 90.2 score on a scale | Standard Deviation 24 |
| Stereotactic Radiotherapy | Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form | Hormonal Domain | 94.4 score on a scale | Standard Deviation 8.6 |