Clinical trial · Interventional
IG-VMAT for Localized Prostate Cancer
A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer
- 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)
To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
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 |
|---|---|---|---|
| convention | Radiation | — | UNRESOLVED |
| hypofraction | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hypofraction
- description
- 70 Gy in 28 fractions over 5.6 weeks
- interventionNames
- Radiation: hypofraction
- type
- ACTIVE_COMPARATOR
- label
- convention
- description
- 80Gy in 40 fractions over 8 weeks
- interventionNames
- Radiation: convention
Primary outcomes (1)
- measure
- Biochemical progression free survival
- timeFrame
- up to 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Age 50-79 * Histologically confirmed prostate adenocarcinoma * Clinical stage T1-3N0M0 according to the AJCC 6th edition * Gleason score must be \>5 * KPS \>70 * No radical surgery or cryosurgery for prostate cancer Exclusion Criteria: * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible) * Evidence of distant metastases * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * Previous or concurrent cytotoxic chemotherapy for prostate cancer
References
Publications (0)
Data not yet available