Clinical trial · Interventional
SBRT in 4 Fractions for Prostate Cancer
Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer
NCT03873090CI-TRIAL-00037562completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be \[ 4 x 9.5 Gy = 38 Gy \] delivered in 5 alternative days.
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 |
|---|---|---|---|
| SBRT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT in 4 fraction
- description
- Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT
- interventionNames
- Other: SBRT
Primary outcomes (2)
- measure
- Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
- timeFrame
- up to 5 years
- description
- Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
- measure
- Tumour response to local radiation therapy by assessing freedom from biochemical failure.
- timeFrame
- up to 5 years
- description
- Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≤ 85years. * WHO performance status ≤ 2. * PSA\>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c. * Histologically proven prostate adenocarcinoma * No pathologic lymph nodes on CT/ MRI scan. * No distant metastases. * No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT). * No malignant tumours in the previous 5 years. * IPSS 0-7. * Combined HT according to risk factors. * Informed consent. Exclusion Criteria: * Prostate size greater than 60cc. * Previous TURP less than 6 weeks before radiotherapy. * Previous prostate surgery other than TURP. * Diabetes \*. * Use of anticoagulants drugs \*. * Chronic inflammatory bowel disease \*. * Previous pelvic irradiation. * Inability to obtain written informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.