Clinical trial · Interventional
Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer
A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer
NCT00946543CI-TRIAL-00011918unknownPhase 1ClinicalTrials.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)
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
Secondary outcomes (6)
- measure
- Overall survival
- measure
- Local control
- measure
- PSA control
- measure
- Acute side effects as assessed weekly by the RTOG scoring system
- measure
- Quality of life
- measure
- Patterns of recurrence
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of prostate cancer meeting 1 of the following criteria: * Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases * Localized disease (stage pT2-T4) with \> 30% estimated risk of pelvic nodal metastases * High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the National Collaborative Cancer Network (NCCN) * Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node involvement * Candidate for radical radiotherapy PATIENT CHARACTERISTICS: * No inflammatory bowel disease or other small bowel disease PRIOR CONCURRENT THERAPY: * No prior pelvic radiotherapy or surgery (excluding prostatectomy)
References
Publications (1)
- DERIVEDFernandez-Mateos J, Cresswell GD, Trahearn N, Webb K, Sakr C, Lampis A, Stuttle C, Corbishley CM, Stavrinides V, Zapata L, Spiteri I, Heide T, Gallagher L, James C, Ramazzotti D, Gao A, Kote-Jarai Z, Acar A, Truelove L, Proszek P, Murray J, Reid A, Wilkins A, Hubank M, Eeles R, Dearnaley D, Sottoriva A. Tumor evolution metrics predict recurrence beyond 10 years in locally advanced prostate cancer. Nat Cancer. 2024 Sep;5(9):1334-1351. doi: 10.1038/s43018-024-00787-0. Epub 2024 Jul 12. PMID 38997466