Clinical trial · Interventional
A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer
A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer
- 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)
Stereotactic body radiotherapy (SBRT) has emerged as an effective and safe treatment for low and intermediate-risk prostate cancer(PCa). However, there is no study that has investigated the effectiveness and safety of SBRT with pelvic radiation and gross target volume(GTV) boost for high-risk prostate cancer patients yet. The investigators designed a phase II clinical study of SBRT with pelvic radiation and GTV boost based on mpMRI in patients with high-risk prostate cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Efficacy | — | UNRESOLVED | — |
| High-risk | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Safety | — | UNRESOLVED | — |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- stereotactic body radiotherapy
- description
- Long-term ADT of 2-3years were administered. Neoadjuvant ADT within 6 months was allowed.Then patients with high-risk prostate cancer recieve stereotactic body radiotherapy with pelvic radiation and GTV boost based on multiparameter magnetic resonance image.
- interventionNames
- Radiation: stereotactic body radiotherapy
Primary outcomes (1)
- measure
- biochemical relapse-free survival
- timeFrame
- three months
- description
- 2-years biochemical relapse-free survival
Secondary outcomes (4)
- measure
- the incidence rate of acute toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * pathologically confirmed high-risk (T3a or Gleason score ≥ 8 or a PSA \> 20 ng/ml) prostate cancer * a WHO performance status 0-1 * history of neoadjuvant androgen deprivation therapy(ADT) within 6 months before enrollment * Patients with pelvic positive lymph node were also included in our study Exclusion Criteria: * distant metastasis * history of neoadjuvant ADT over 6 months before enrollment * history of definitive treatment for prostate cancer such as radical prostatectomy * history of pelvic irradiation; prostate volume≥100 cm3
References
Publications (0)
Data not yet available