Adenocarcinoma of the Prostate, Stage III Prostate Cancer
Conditions
Brief summary
This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVES: I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials. II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer. III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer. OUTLINE: Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician. After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.
Interventions
RADIATIONstereotactic body radiation therapy
Undergo SBRT
OTHERquality-of-life assessment
Ancillary studies
OTHERlaboratory biomarker analysis
Correlative studies
DRUGandrogen deprivation therapy
up to 9 months at the discretion of the treating physician
Sponsors
Jonsson Comprehensive Cancer Center
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 primary non-metastatic adenocarcinoma of the prostate * Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors: * Pre-biopsy prostate-specific antigen (PSA) \>= 20 * Biopsy Gleason score 8-10 * Clinical stage T3 * No pelvic nodal metastases (based on computed tomography \[CT\] or magnetic resonance imaging \[MRI\] findings) * No distant metastases, based upon: * CT scan or MRI of the pelvis within 120 days prior to registration * Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis * Karnofsky performance status (KPS) \>= 70 * Ability to understand, and willingness to sign, the written informed consent * Patient will have opted for SBRT among definitive treatment choices
Exclusion criteria
* Patients with any evidence of distant metastases * Hormonal therapy (luteinizing hormone-releasing hormone \[LHRH\] agonist or oral anti-androgen) exceeding 4 months prior to registration * Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate * Prior pelvic radiotherapy * History of Crohn’s disease or Ulcerative colitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical progression free survival | At 3 years | Biochemical progression is defined as rising PSA profile of \> 2 ng/mL above post-SBRT nadir. |
| Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4 | At 4 months | — |
| Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4 | Up to 5 years | — |
| Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire | Baseline to up to 5 years | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmar Kishan
Jonsson Comprehensive Cancer Center
Outcome results
None listed