Clinical trial · Interventional
Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer
Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
NCT01505075CI-TRIAL-00048474pHART8unknownPhase 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 (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).
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 radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated radiation
- description
- 40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles
- interventionNames
- Radiation: Hypofractionated radiation
Primary outcomes (1)
- measure
- Incidence of grade 3+ rectal toxicity
- timeFrame
- Acute period (up to 3 months)
- description
- Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Secondary outcomes (4)
- measure
- Incidence of grade 3+ urinary toxicity
- timeFrame
- Acute (up to 3 months) and Late (after 6 months of follow-up)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * informed consent obtained * men \> 18 years * histologically confirmed prostate adenocarcinoma (centrally reviewed) * high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA \> 20ng/mL Exclusion Criteria: * prior pelvic radiotherapy * anticoagulation medication (if unsafe to discontinue for gold seed insertion) * diagnosis of bleeding diathesis * pelvic girth \> 40cm (to ensure visibility of gold seeds on electronic portal imaging) * large prostate (\> 90cm3) on imaging * severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \> 3) * No evidence of castrate resistance (defined as PSA \< 3ng/mL while testosterone is \< 0.7nmol/L). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression
References
Publications (0)
Data not yet available
No reference posted for this study.