Clinical trial · Interventional
Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer
Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV
- 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)
A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphatic Metastasis | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIB Dose-Escalation Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SIB Dose-Escalation radiotherapy
- description
- Simultaneous integrated boost to intraprostatatic tumor and lymph nodes
- interventionNames
- Radiation: SIB Dose-Escalation Radiotherapy
Primary outcomes (1)
- measure
- PSA progression free survival
- timeFrame
- 36 months
- description
- PSA progression defined according to American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix definition: nadir PSA + 2 ng/mL (on three consecutive measurements with at least one month between each)
Secondary outcomes (4)
- measure
- Genitourinary Quality of Life
- timeFrame
- 0 6 12 36 60 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed high risk prostate cancer with a risk of lymphatic spread \>15% according to the MSKCC nomogram (1) http://nomograms.mskcc.org/Prostate/PreTreatment.aspx * Written informed consent * \> 18 years * Fiducial gold markers implanted in the prostate (min 3) Exclusion Criteria: * • Non MR-safe implants or other contraindication to MRI * WHO PS\>1 * Previous pelvic irradiation * TURP within 6 months * IPSS \>19 * Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis * Creatinin clearance \< 30ml/min according to http://www.fass.se/LIF/produktfakta/kreatinin.jsp
References
Publications (0)
Data not yet available