Clinical trial · Interventional
Stereotactic Body Radiotherapy for Prostate Cancer
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer
NCT01352598CI-TRIAL-00047296completedN/AResults postedClinicalTrials.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 study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Stereotactic Body Radiotherapy
- description
- Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
- interventionNames
- Radiation: stereotactic body radiotherapy
Primary outcomes (1)
- measure
- Biochemical Control Rate
- timeFrame
- one year
- description
- Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age \>= 18 years * Zubrod performance status of 0-3 * T1-3 N0 M0 adenocarcinoma of the prostate * Prostate volume ≤ 100 cc * Signed study-specific consent form Exclusion Criteria * Extension of local tumor to involve adjacent organs other than seminal vesicles (T4) * Prostate volume \> 100 cc * Nodal involvement * Metastatic disease * Prior pelvic radiotherapy except as part of combination therapy for prostate cancer * History of scleroderma * Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.