Clinical trial · Interventional
Prostatectomy Adaptive Radiation Therapy (ART)
A Feasibility Study of Post-operative Adaptive Radiation Therapy for 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)
This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-operative Adaptive Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Post-Operative adaptive radiotherapy
- description
- All Patients enrolled in this study will have additional scans (Cone-Beam CT, MRI) daily during their treatment. This extra imaging will help us see any changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.
- interventionNames
- Radiation: Post-operative Adaptive Radiation Therapy
Primary outcomes (1)
- measure
- Change in radiation dose delivered to target volumes and normal tissue
- timeFrame
- 5 years
Secondary outcomes (3)
- measure
- Time for radiotherapy replanning
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND * Clinical stage pT3, pT4, or pT2 with positive margin OR * Any p-Stage with a persistently elevated post-operative PSA \> 0.05 ng/ml OR * A delayed rise in PSA post-operatively Exclusion Criteria: * Inflammatory bowel disease or other contraindications to radiotherapy * Prior pelvic radiotherapy * Previous cytotoxic chemotherapy * Radiological or pathologic evidence of nodal metastases. * Planned radiotherapy to pelvic lymph nodes * Evidence of systemic metastases on imaging. * Prosthetic hip replacement * No signed informed consent
References
Publications (0)
Data not yet available