A Phase I/II Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy
Summary
The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.
Arms & interventions
- RadiationHDR brachytherapy
* Dose constraints for 21 Gy: * Bladder and rectum: V70 \< 1 cc * Urethra: V115 \< 1 cc * V135: 0% * Dose constraints for 23 Gy: * Bladder and rectum: V65 \< 1 cc * Urethra: V105 \< 1 cc * V125: 0% * Dose constraints for 25 Gy: * Prostate V100 \>90% (\>95% preferred) * Bladder and rectum: V70 \< 1 cc, Dmax \<115% * Urethra: V110 \< 1 cc, Dmax \<120%
Outcome measures
Primary
Biochemical control experienced by patients with prostate cancer treated with an HDR implant
-Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng/mL or more above the PSA nadir
Time frame: Through 3 years after implant
Secondary
Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant
Time frame: From start of treatment through 90 days
Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant
Time frame: From day 91 through 3 years after implant
Eligibility criteria
Study locations (1)
Washington University School of Medicine
St Louis, Missouri, 63110