Prostatic Neoplasms
Conditions
Brief summary
To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and effective in the treatment of low-risk localized prostate cancer.
Interventions
PROCEDUREHypo-fractionated Radiotherapy
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Eligible patients will have clinical stage T1c through T2b, initial PSA level \<10 and a biopsy Gleason score of 3+3 or 3+4 with fewer than 50% of biopsy cores involved. * Patients who have had any form of prior curative treatment (surgery, radiotherapy, cryotherapy) will not be eligible. A prior course of hormone therapy of less than 3 months duration will be allowed. * Adult men will be considered. * No life expectancy restrictions will apply. * Performance Status will not be considered. * No requirements for organ or marrow function will be made * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- No prior prostate treatment will be allowed. * The use of other concurrent Investigational Agents will not be allowed. * No exclusion requirements due to co-morbid disease or incurrent illness. * No requirements regarding history of allergic reactions. * Pregnancy or nursing patients is not applicable (ie. patients are male).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response that achieves a stable nadir over time. | — |
Countries
United States
Outcome results
None listed