Clinical trial · Interventional
Hypo-fractionated Postoperative IMRT in Prostate Cancer
Hypofractionated Post-operative IMRT in Prostate Carcinoma: a Phase I/II Study
- 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)
To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Median follow-up was 30 months.
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 |
|---|---|---|---|
| Hypo-fractionated postoperative IMRT-SIB | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Hypo-fractionated postoperative IMRT-SIB
- description
- All patients underwent combined, intensified and modulated radiotherapy for five days a week with the following doses: 62.5 Gy to the prostate bed and 45 Gy to pelvis nodes in 25 fractions.
- interventionNames
- Radiation: Hypo-fractionated postoperative IMRT-SIB
Primary outcomes (1)
- measure
- incidence of early treatment-emergent adverse events
- timeFrame
- < 90 days
- description
- adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale.
Secondary outcomes (2)
- measure
- Biochemical relapse free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 years * prior radical prostatectomy with or without lymphadenectomy * high-risk patients (positive surgical margins, and/or extracapsular extension, and/or seminal vescicle invasion, and/or probability of nodal metastasis \> 7% calculated by the Roach formula after pelvic lymph node dissection with ≤ 13 nodes removed, and/or presence of any positive pelvic nodes) or patients with biochemical relapse (initial post-surgery serum PSA equal or above 0.2 ng/mL with a second confirmatory PSA of the same value) * ECOG performance status 0-1 * adequate bone marrow function (hemoglobin concentration \> 8 g/dl, white blood cell count \> 3,000/ mm³, platelet count \> 75,000/ mm³) * pre-treatment computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis * bone scan * informed consent Exclusion Criteria: * prior pelvic radiotherapy * distant metastases * macroscopic residual tumor * pelvic or para-aortic nodes at re-evaluation imaging after surgery * secondary malignancies * genetic syndromes of hyper-radio-sensitivity * chronic inflammatory bowel disease * previously treated with androgen deprivation therapy * previously treated with chemotherapy for prostate cancer
References
Publications (0)
Data not yet available