Clinical trial · Interventional
Surgery Combined With Intensity Modulated Radiation Therapy - Image-Guided Radiation Therapy (IMRT-IGRT) in Locally-advanced Prostate Cancers
Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers
- 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)
Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate: * pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV); * a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).
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 |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery combined with IMRT-IGRT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery combined with IMRT-IGRT
- interventionNames
- Procedure: Surgery combined with IMRT-IGRT
Primary outcomes (1)
- measure
- Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity)
- timeFrame
- between 6 months and 3 years
- description
- Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed between 6 months and 3 years after the beginning of the radiotherapy.
Secondary outcomes (7)
- measure
- Dose received by the rectum and the bladder with and without seminal vesicles irradiation
- timeFrame
- Before treatment
- description
- Assessed using a dose-volume histogram
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18, * Prostate adenocarcinoma (histologically proven), * Locally-advanced (T3a or Gleason \> 7 or PSA ≥ 20 ng/mL), * Distal half of seminal vesicles unaffected on MRI, * Non metastatic cancer: negative extension assessment (on prostatic and pelvic MRI and bone scintigraphy), * Radiotherapy and hormonotherapy indication, * Medical insurance affiliation, * Written informed consent. Non-inclusion criteria: * Co-morbidity or medical history contraindicating surgery (pelvic lymphadenectomy and seminal vesicle ablation), * Contraindication to pelvic irradiation, * Hip prosthesis, * History of cancer for the last 5 years (except baso-cellular epithelioma), * History of pelvic irradiation, * Person deprived of freedom or under guardianship, * Participation in another biomedical research. Exclusion Criteria: * Surgery showing lymph nodes involvement (pelvic radiation indication) * Surgery without ablation of seminal vesicles * Surgery with positive margins in seminal vesicles
References
Publications (0)
Data not yet available