At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed early stage prostate cancer
- ✓Low-risk disease (T1-T2a, Gleason ≤6, PSA <10 ng/mL) or favorable intermediate-risk (Gleason 3+4=7, <50% positive biopsy cores, ≤1 NCCN intermediate risk factor)
- ✓Age at least 18 years
- ✓ECOG performance status ≤2
- ✕Prior radiation therapy to prostate or lower pelvis
- ✕Other malignancy within 5 years (except skin cancer treated with local resection)
- ✕Currently receiving other investigational agents
- ✕Uncontrolled intercurrent illness (infection, heart failure, angina, arrhythmia)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating HDR brachytherapy for Prostate Cancer and Prostate Neoplasm. Currently recruiting, targeting 36 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
* 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%