Clinical trial · Interventional
Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer
RAdiation Dose TAiloRing Guided by Enhanced Targeting
- 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 is a phase II non-blinded randomized controlled trial of image-guided, tumor-focused radiotherapy in patients with intermediate- or high-risk prostate cancer planning to undergo definitive radiotherapy with or without systemic therapy. The image-guided, tumor-focused radiotherapy will be compared to standard, whole-prostate treatment. The investigators hypothesize that tumor-focused radiotherapy reduces the radiation dose to organs close to the prostate, possibly leading to decreased acute toxicity to the genitourinary and gastrointestinal organs. The investigators will measure acute and late genitourinary and gastrointestinal toxicity due to radiation and regardless of cause. The investigators will also measure overall survival, metastasis-free survival, and quality of life, as well as biomarkers that may help predict, in the future, who may have a worse toxicity following radiation therapy.
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 |
|---|---|---|---|
| Image-guided tumor-focused radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of care dose radiotherapy
- description
- Standard dose radiation therapy
- type
- EXPERIMENTAL
- label
- Tumor-focused radiotherapy
- description
- Image-guided tumor-focused radiation therapy
- interventionNames
- Radiation: Image-guided tumor-focused radiation therapy
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- 3 months
- description
- Acute any attribution genitourinary or gastrointestinal toxicity (grade 2 or higher), compared between randomized arms, defined as the percentage of patients with Common Terminology Criteria for Adverse Events genitourinary or gastrointestinal toxicity of grade 2 or higher within 3 months of completing radiation therapy. Based on the Common Terminology Criteria for Adverse Event, grade 1 is the lowest and grade 5 is the highest. Grade 5 represents the worst outcome (death).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * At least 18 years old * Histologic confirmation of prostate adenocarcinoma with plan for curative-intent radiation therapy * Lesion visible on prostate Magnetic Resonance Imaging and/or Prostate-Specific Membrane Antigen Positron Emission Tomography-Computed Tomography (according to the treating physician) with concordant pathology from biopsy needle locations. * For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during the radiation therapy treatment and for at least 6 months afterward. Exclusion Criteria: * Bilateral hip implants * Prior prostatectomy * Prior prostate cancer treatment (for example, focal therapy). Note that participants who started hormone therapy within the 90 days prior to randomization are eligible, as long as study-compatible imaging was performed within the 4 months prior to starting the hormone therapy. * Prior radiation therapy to an area requiring treatment in the present study
References
Publications (0)
Data not yet available