Prostatic Neoplasm
Conditions
Keywords
Neoplasms, Urogenital neoplasm, Genital neoplasms, male
Brief summary
The purpose of this study is to evaluate a short course (five radiation treatments) of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.
Detailed description
External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.
Interventions
RADIATIONRadiation Therapy
Stereotactic Body Radiation Therapy
Sponsors
Sharp HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Radiotherapy: phase 1/2 (but no drug, biological/vaccine or combination product used)
Eligibility
Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.
Exclusion criteria
* Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity. | Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Biochemical Disease-free Status | mean 41 months (range 3-84 months) | Patients will be followed after completion of treatment with PSA tests every 6-12 months Patients will be deemed to have biochemical failure if the post-treatment PSA increases by 2 ng/ml or more above the post-radiation nadir PSA. Patients who do not qualify as having biochemical failure will be deemed as biochemically disease-free. |
Countries
United States
Participant flow
Recruitment details
Between 2011 and 2018 patients with prostate cancer were enrolled from the Radiation Oncology clinic.
Participants by arm
| Arm | Count |
|---|---|
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Radiation Therapy: Prostate Stereotactic Body Radiation Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 6 / 12 |
| serious Total, serious adverse events | 2 / 12 |
Outcome results
Primary
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales.
Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant.
Time frame: Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.
Population: 12 participants who were enrolled in the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Genitourinary Toxicity: 0 (none) | 11 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Genitourinary Toxicity Grade 1 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Genitourinary Toxicity Grade 2 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Genitourinary Toxicity Grade 3 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Genitourinary Toxicity Grade 4 | 1 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Genitourinary Toxicity Grade 5 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Lower Gastrointestinal Toxicity: 0 (none) | 12 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Lower Gastrointestinal Toxicity Grade 1 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Lower Gastrointestinal Toxicity Grade 2 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Lower Gastrointestinal Toxicity Grade 3 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Lower Gastrointestinal Toxicity Grade 4 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Acute Lower Gastrointestinal Toxicity Grade 5 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Genitourinary Toxicity: 0 (none) | 8 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Genitourinary Toxicity Grade 1 | 4 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Genitourinary Toxicity Grade 2 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Genitourinary Toxicity Grade 3 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Genitourinary Toxicity Grade 4 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Genitourinary Toxicity Grade 5 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Gastrointestinal Toxicity: 0 (none) | 10 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Gastrointestinal Toxicity Grade 1 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Gastrointestinal Toxicity Grade 2 | 2 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Gastrointestinal Toxicity Grade 3 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Gastrointestinal Toxicity Grade 4 | 0 participants |
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. | Late Gastrointestinal Toxicity Grade 5 | 0 participants |
Secondary
Rate of Biochemical Disease-free Status
Patients will be followed after completion of treatment with PSA tests every 6-12 months Patients will be deemed to have biochemical failure if the post-treatment PSA increases by 2 ng/ml or more above the post-radiation nadir PSA. Patients who do not qualify as having biochemical failure will be deemed as biochemically disease-free.
Time frame: mean 41 months (range 3-84 months)
Population: 12 participants who were enrolled in the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiation Therapy: Prostate Stereotactic Body Radiation Therapy | Rate of Biochemical Disease-free Status | 10 participants |