Clinical trial · Interventional
Dose Escalation Using Fiducial Markers in Image Guided Volumetric Modulated Arc Therapy to the Focal Lesion Micro Boost of Localized Prostate Cancer
The Impact of Dose Escalation Using Gold Markers in Image Guided Volumetric Modulated Arc Radiotherapy to the Focal Lesion Micro Boost of 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)
Gold markers implanted in the prostate are used frequently for position verification of the prostate during external-beam radiotherapy. By using the markers as a surrogate for the prostate itself, not only set-up errors, but also the internal motion of the prostate relative to the bony anatomy can be identified. It is thus believed that escalated dose marker guided radiotherapy should result in better biochemical control compared to conventional external beam radiotherapy, with a similar or lower incidence of toxicity. However, clinical data to support this is still limited. The purpose of this study is to directly compare late toxicity as well as biochemical control between patients treated with dose escalated marker guided radiotherapy versus conventional dose non-marker guided radiotherapy who has otherwise been treated with similar radiotherapy planning techniques and equipment. Prostate magnetic resonance imaging has undergone several technical improvements and shows promises for prostate tumor detection and localization. In addition to morphological information, magnetic resonance imaging allows an estimation of physiological properties of tissues. Diffusion-weighted magnetic resonance imaging is sensitive to restriction of diffusion of water molecules, and dynamic contrast enhanced magnetic resonance imaging can analyze tissue micro vascular properties. Multi para metric magnetic resonance imaging combining Diffusion-weighted and Dynamic contrast enhanced has demonstrated its value in distinguishing malignant from benign prostate tissue. Higher radiation dose levels were consistently associated with improved biochemical control outcomes and reduction in distant metastases. Radiation dose was one of the important predictors of long-term biochemical tumor control. Dose levels \< 70.2 Grey and 70.2-79.2 Grey were associated with 2.3 and 1.3-fold increased risks of pro static specific antigen relapse compared with higher doses. However, further dose escalation to the whole gland is limited due to an unacceptable high risk of acute and late toxicity. Moreover, local recurrences often originate at the location of the macroscopic tumor, so boosting the radiation dose at the macroscopic tumor within the prostate might increase local control. A reduction of distant metastases and improved survival can be expected by reducing local failure. Treating the dominant focus or boosting the dose to this area while reducing the dose to as much healthy tissue as possible has significant potential for improving treatment.
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 Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose escalation to prostate focal lesion | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escaltion
- description
- insertion of 3 fiducial markers, prostate will receive 78 Gy with dose escalation to prostate focal lesion up to 87 Gy
- interventionNames
- Radiation: Dose escalation to prostate focal lesion
Primary outcomes (1)
- measure
- Measurement of systemic error in mm and random error in cm in the different three direction X-Y-Z
- timeFrame
- 12 months
- description
- Position verification will be done guided with implanted gold markers with daily portal imaging (AP \& lateral) correction protocol in mediolateral, superior-inferior \& inward-outward directions by mm for 35 fraction. The off-line portal pre-correction images will be verified daily to detect average shifts in the three diresctions. Random or inter-fraction errors which are deviations between different fractions will be taken weekly during a treatment series. Systematic errors Which are deviations between the planned patient position and the average patient position of a course of fractioned therapy will be taken in the first three settings. The mean and standard deviation (SD) of the systematic error and SD of random errors will be analyzed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Performance status ECOG: 0-2 2. Pathologically proven prostatic adenocarcinoma. 3. Localized prostate cancer (Gleason's score: 2-10, Baseline serum prostatic antigen: \>4 ng/dl, T1a-T3b). 4. No extra prostatic invading adjacent structures. 5. Adequate hematological, renal \& hepatic profile. 6. Insertion of more than one fiducial marker in the prostate. 7. Patient did verbal \& written consent and adherence to treatment. Exclusion Criteria: 1. Patient weight \>130 kg. 2. Performance status EGOG: 3-4. 3. Distant metastasis. 4. Previous pelvic radiotherapy. 5. Previous prostatectomy. 6. Urinary bladder stones. 7. General contraindications for MRI (i.e. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent). 8. Concomitant neoplastic disease or previous anti neoplastic therapy.
References
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