Metastatic Prostate Cancer
Conditions
Keywords
Metastatic prostate cancer
Brief summary
The investigators aim to test the safety and feasibility of prostate gland stereotactic body radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.
Detailed description
The investigators and other investigators have previously documented the safety and efficacy of definitive intent stereotactic body radiotherapy (SBRT) in the treatment of localized prostate cancer. In the metastatic setting for multiple malignancies, improved survival rates and disease outcomes have been shown with definitive treatment of the primary disease site. This concept of cytoreductive surgery or decreasing the primary tumor burden is now considered the standard of care for metastatic colon, ovarian, renal cell, and some breast carcinomas (plus post-surgery irradiation). With new guidelines and declining rates of PSA screening, the incidence of newly diagnosed metastatic prostate cancer is expected to increase. A recent population-based study has concluded significant improvements in the definitive treatment of the local prostate cancer in the stage IV setting with either radical prostatectomy or conventional prostate radiation treatments/brachytherapy. To our knowledge, one prospective phase II trial is currently accruing patients to best systemic therapy or best systemic therapy (BST) plus definitive treatment with either radical prostatectomy or conventionally fractionated radiation therapy The investigators hypothesize that the addition of primary disease SBRT to best systemic therapy for newly diagnosed metastatic prostate cancer would be associated with an acceptable safety profile, quality of life, disease progression, and overall survival. The addition of SBRT to best systemic therapy is also expected to be better-received for stage IV patients (with relatively limited prognosis), vs. fully fractionated radiation therapy, brachytherapy, or radical prostatectomy. The above endpoints would initially be tested in a prospective phase II multi-institutional trial and in comparison with historical controls.
Interventions
RADIATIONSTEREOTACTIC BODY RADIOTHERAPY to the prostate gland
Sponsors
Sharp HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically-confirmed, adenocarcinoma of the prostate * Clinical Stage T1b - T4, NX-0-1, M1 * Any Gleason score * PSA\<1000 * ECOG Performance Status 0-2 * No prior prostate radiation or other definitive therapy
Exclusion criteria
* Prior prostatectomy or cryotherapy of the prostate * Prior radiotherapy to the prostate or lower pelvis * Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion * Chemotherapy for a malignancy in the last 5 years * History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation related toxicity | 5 years | Radiation related toxicity as per history and physical, and 1 or several of Patient questionnaires: SF-12 questionnaire AUA questionnaire EPIC-26 questionnaire SHIM questionnaire Utilization of Sexual Medications/Devices questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 3-4 years | Feasibility in terms of accrual and practical treatment delivery |
Countries
United States
Outcome results
None listed