Clinical trial · Interventional
Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer
Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
NCT01146340CI-TRIAL-00041005PHART6completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT
- description
- SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT
- interventionNames
- Radiation: Hypofractionated radiotherapy
Primary outcomes (1)
- measure
- Incidence of grade 3+ rectal toxicity
- timeFrame
- Acute period (<3 months)
- description
- Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Secondary outcomes (4)
- measure
- Incidence of grade 3+ urinary toxicity
- timeFrame
- Acute (<3 months) and Late (>6 months)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men \>18 years * Histologically confirmed prostate adenocarcinoma * Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score \<=6, and PSA \<15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA \<=10 ng/mL Exclusion Criteria: * Prior pelvic radiotherapy * Anticoagulation medication (if unsafe to discontinue for gold seed insertion) * Diagnosis of bleeding diathesis * Presence of a hip prosthesis * Pelvic girth \>40cm - Large prostate (\>90cm3) on imaging * Severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \>3)
References
Publications (1)
- DERIVEDQuon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016. PMID 27622157