Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate
Conditions
Keywords
Radiation, Stereotactic Radiosurgery, Radiotherapy, Prostate Tumor, Prostate Surgery, CyberKnife
Brief summary
The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.
Interventions
RADIATIONCyberKnife Stereotactic Radiosurgery
Five treatments given over about one week.
Sponsors
Swedish Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven prostate adenocarcinoma * Clinical stage T1a-T3, N0-Nx, M0-Mx * Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA\<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA\<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 & \<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20 * Karnofsky performance status 70-100 * Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy * Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment * High risk group: three hormone therapy regimens are allowed * 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed
Exclusion criteria
* Prior prostatectomy or cryotherapy of the prostate * Prior high-dose 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life outcomes (low- and intermediate-risk prostate cancer groups) | 8 years | In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial. |
| Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group) | 8 years | In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of toxicities related to treatment | 5 years | After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment. |
| Disease free survival | 5 years | Measure disease free survival after five years following cyberknife stereotactic radiosurgery. |
| Overall survival | 5 years | Measure overall survival after five years following cyberknife stereotactic radiosurgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 5 years | Measure quality of life after five years following cyberknife stereotactic radiosurgery. |
Countries
United States
Contacts
Primary ContactMary Monahan
Backup ContactRobert Meier, MD
Outcome results
None listed