Clinical trial · Interventional
External Beam Radiation Therapy - Target Volume
A Pilot Study to Develop a Technique for External Beam Radiotherapy After Radical Prostatectomy Based on MRI-Delineation of the Clinical Target Volume
- 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)
Delivery of conformal radiation therapy following radical prostatectomy is limited by the inability to define the clinical target volume (CTV). This stems from a poor understanding of patterns of local recurrence and limitations of standard imaging techniques.Magnetic Resonance Imaging (MRI) is a promising modality for imaging the prostatic bed following radical prostatectomy. MRI provides more detailed postoperative anatomy to guide CTV delineation, the ability to document local recurrence patterns, and a method to assess intrafraction prostatic bed motion and deformity to define appropriate planning target volume margins. The aim of this pilot study is to develop a technique for external beam radiation therapy (EBRT) following radical prostatectomy based on MRI-delineation of the CTV. Twenty patients will be enrolled in this pilot, development phase.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- External Beam Radiation Therapy
- interventionNames
- Procedure: External Beam Radiotherapy
Primary outcomes (1)
- measure
- To develop a technique for MRI-delineation of the clinical target volume (CTV) for EBRT following radical prostatectomy
- timeFrame
- After data acquisition
Secondary outcomes (6)
- measure
- To compare the reproducibility of clinical target volume and rectal wall volume delineation on MRI and CT.
- timeFrame
- After data acquisition
- measure
- To compare the location of the urethral anastomosis defined on MRI as compared to a fiducial marker placed under TRUS-guidance adjacent to the anastomosis.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients following radical prostatectomy for prostate adenocarcinoma with one or more of the following adverse features: pT2 + positive surgical margins ) pT3 ) PSA ≤ 2ng/ml Persistently elevated PSA at 3 months ) * Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse * Patients being planned for radiation therapy * No evidence of distant metastases * Age ≥ 18 years * ECOG performance status 0 or 1 * Informed consent Exclusion Criteria: * Contraindications to MRI Patients weighing \>136 kgs (weight limit for the scanner tables) Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI. * Severe claustrophobia * Inflammatory bowel disease or collagen vascular disease * Previous colorectal surgery * Previous pelvic radiotherapy
References
Publications (0)
Data not yet available