Clinical trial · Interventional
3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer
Randomized Phase III Trial of 3D Conformal Radiotherapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer
NCT00326638CI-TRIAL-00044723unknownN/AClinicalTrials.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)
In this study we are comparing two forms of radiotherapy. This study is being done because it is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm A: 3D-Conformal Radiation | Other | — | UNRESOLVED |
| Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A: 3D-Conformal Radiation
- description
- Intervention: Standard radiation treatment for high risk prostate cancer. Once daily Monday to Friday for 8 weeks. 3DCRT 7800 cGY/39 Fractions/ STD Technique\* * Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23 * Boost 6 F 3DCRT to Prostate 3,200 cGy/16
- interventionNames
- Other: Arm A: 3D-Conformal Radiation
- type
- EXPERIMENTAL
- label
- Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy
- description
- Intervention: Helical Tomotherapy Intensity Modulated Radiotherapy (IMRT) once daily Monday to Friday for 8 weeks. IMRT using Helical Tomotherapy\* 7800 cGY/39 Fractions Boost IMRT to Prostate 3,200 cGy/16
- interventionNames
- Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. A pathologic diagnosis of adenocarcinoma of the prostate 2. Age greater than 18 years 3. ECOG performance status of 2 or less. 4. Presence of any of the following high risk features: * Clinical stage cT3-4 or * Gleason score 8-10 or * Pre-treatment PSA \> 20ng/ml or * Clinical N1/N2 or pathologic N1/N2 Exclusion Criteria: 1. Patients with contraindication to radical radiation therapy including inflammatory bowel disease 2. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer 3. Prior pelvic radiotherapy for other malignancies 4. Prior cytotoxic chemotherapy 5. Prior orchiectomy, radical prostatectomy, cryotherapy or thermal ablation therapy for prostate cancer
References
Publications (0)
Data not yet available
No reference posted for this study.