Prostate Cancer
Conditions
Keywords
prostate cancer, stereotactic radiotherapy
Brief summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
Detailed description
This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Interventions
RADIATIONstereotactic body radiotherapy
Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Sponsors
Mercy Research
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
* Patient age \>= 18 years * Zubrod performance status of 0-3 * T1-3 N0 M0 adenocarcinoma of the prostate * Prostate volume ≤ 100 cc * Signed study-specific consent form
Exclusion criteria
* Extension of local tumor to involve adjacent organs other than seminal vesicles (T4) * Prostate volume \> 100 cc * Nodal involvement * Metastatic disease * Prior pelvic radiotherapy except as part of combination therapy for prostate cancer * History of scleroderma * Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Control Rate | one year | Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The Phoenix definition for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Toxicity Rate | one year | Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stereotactic Body Radiotherapy Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions.
For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. | 84 |
| Total | 84 |
Baseline characteristics
| Characteristic | Stereotactic Body Radiotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 61 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 68 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 11 Participants |
| Race (NIH/OMB) White | 66 Participants |
| Region of Enrollment United States | 84 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 72 |
| other Total, other adverse events | 5 / 74 |
| serious Total, serious adverse events | 1 / 74 |
Outcome results
Primary
Biochemical Control Rate
Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The Phoenix definition for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.
Time frame: one year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Biochemical Control Rate | Complete, partial, or stable tumor control | 71 Participants |
| Stereotactic Body Radiotherapy | Biochemical Control Rate | Disease progression | 0 Participants |
Secondary
Late Toxicity Rate
Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.
Time frame: one year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Late Toxicity Rate | Patients who experienced no adverse events | 68 Participants |
| Stereotactic Body Radiotherapy | Late Toxicity Rate | Patients who experienced adverse events | 6 Participants |