Clinical trial · Interventional
Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate
A Phase I/II Study of Dose Escalated Intensity Modulated Radiation Therapy (IMRT) for the Treatment of Pelvic Lymph Nodes and Primary Tumour in Patients With Carcinoma of the Prostate
- 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 feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer. All eligible patients with high risk prostate cancer who are going to have primary radiation therapy to the pelvic lymph nodes and prostate seminal vesicles with or without concurrent hormonal therapy will be approached regarding study entry.
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 |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose Escalated IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT in prostate cancer
- interventionNames
- Radiation: Dose Escalated IMRT
Primary outcomes (1)
- measure
- Determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer.
- timeFrame
- after all patients have completed study intervention
Secondary outcomes (1)
- measure
- acute toxicity of therapy;prostate motion when pelvic radiotherapy is delivered;treatment time required to deliver IMRT to the pelvic lymph nodes, prostate and seminal vesicles
- timeFrame
- after all patients have completed study intervention
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * A histologic diagnosis of adenocarcinoma of the prostate within six months of entry. * Clinical Stage T1-T2 with (PSA \>20 or Gleason score \>7) * Clinical Stage T3, T4 * Bone scan reported as negative for metastases within 6 months of study entry. * All patients must have a CT scan of the abdomen and pelvis reported as negative for nodal metastases within 12 wks of study entry. * The patient must not have received greater than 6 months of hormonal therapy. * The patient must not have received cytotoxic anticancer therapy prior to study entry. * Patients must have an ECOG performance status of 2 or less. * Age 80 years old or less * Signed informed consent Exclusion Criteria: * Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy * Patients with prior colorectal surgery * Patients with prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
References
Publications (1)
- BACKGROUNDBayley A, Rosewall T, Craig T, Bristow R, Chung P, Gospodarowicz M, Menard C, Milosevic M, Warde P, Catton C. Clinical application of high-dose, image-guided intensity-modulated radiotherapy in high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):477-83. doi: 10.1016/j.ijrobp.2009.05.006. Epub 2009 Sep 3. PMID 19733014