Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer
Conditions
Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the ProstateSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Mary Monahan
- 206-320-7029
- [email protected]
Principal Investigator
- Robert Meier, MD
Eligibility Criteria
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
Study Plan
CyberKnife Stereotactic Radiosurgery
EXPERIMENTAL
This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.
RADIATION:
CyberKnife Stereotactic RadiosurgeryDescription:
Five treatments given over about one week.
Outcome Measures
Primary Outcome Measures
Quality of life outcomes (low- and intermediate-risk prostate cancer groups)
Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)
Secondary Outcome Measures
Rates of toxicities related to treatment
Disease free survival
Overall survival
Timeline
Last Updated
July 12, 2019Start Date
January 8, 2015Today
February 5, 2025Completion Date ( Estimated )
December 1, 2024
Sponsors of this trial
Lead Sponsor
Swedish Medical Center