Clinical trial · Interventional
Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer
Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): termination of the trial after interim analysis. the main criterion could not be reached
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen deprivation | Drug | — | UNRESOLVED |
| Simultaneous integrated boost intensity-modulated arctherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation
- interventionNames
- Radiation: Simultaneous integrated boost intensity-modulated arctherapy
- Drug: Androgen deprivation
Primary outcomes (1)
- measure
- Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
- timeFrame
- From start of radiotherapy to six months after the end of radiotherapy
- description
- Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate 2. High risk localized adenocarcinoma defined by at least one of the following criteria: * Clinical stage T2c, T3 or T4 * Gleason score ≥ 8 * Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml 3. Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy) 4. No pelvic adenopathy ≥ 15 mm on CT or MRI, 5. Absence of bone and/or visceral metastasis 6. Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation 7. Absence of prior pelvic radiotherapy, 8. Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy, 9. Age ≥ 18 years and ≤ 85 years 10. ECOG performance status ≤ 1, 11. Estimated life expectancy \> 5 years 12. Membership of a social security system, 13. Signed informed consent. Exclusion Criteria: 1. Prostate cancer histology other than adenocarcinoma, 2. pN1 patients (lymph node dissection after histologically proven) 3. PSA \> 100 ng/ml 4. History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin) 5. Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic) 6. Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...) 7. Contra-indication to agonists or antagonists of LH-RH 8. Bilateral hip prosthesis, 9. Patients already included in another clinical trial with an experimental molecule, 10. Persons deprived of liberty or under guardianship 11. Unable to undergo medical test for geographical, social or psychological.
References
Publications (0)
Data not yet available