N/A
Completed N=84
Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer
Source: ClinicalTrials.gov NCT01578902 ↗Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Dec 2020
Primary outcomePrimary: Incidence of Grade 3+ Gastrointestinal Toxicity — 0 participants
Summary
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Grade 3+ Gastrointestinal Toxicity |
— | — |
| SECONDARY Incidence of Grade 3+ Genitourinary Toxicity |
1 | — |
| SECONDARY Incidence of Grade 3+ Rectal and Urinary Toxicity |
1; 0; 0; 1 | — |
| SECONDARY Patient Reported Quality of Life |
22; 16; 33 | — |
| SECONDARY Biochemical (ie. Prostate Specific Antigen) Disease Free Survival |
96 | — |
| SECONDARY Biopsy Positive Rate |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent signed (Appendix A)
- Adult men greater than 18 years of age
- Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
- Clinical stage T1-T2b, Gleason Score 40cm (to ensure visibility of gold seeds on electronic portal imaging device)
- Large prostate (> 60 cm3) on imaging
- Severe lower urinary tract symptoms (International Prostate Symptom Score > 15 or nocturia > 3)
Data sourced from ClinicalTrials.gov (NCT01578902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.