Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer
Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Intermediate Risk Adenocarcinoma of the Prostate
NCT01737151CI-TRIAL-00040364terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Conditions
Conditions (2)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| four fraction split-course SBRT | Radiation | — | UNRESOLVED |
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (standard stereotactic body radiation therapy (SBRT)
- description
- Patients undergo standard daily fractions of SBRT over 7-8.5 weeks
- interventionNames
- Radiation: stereotactic body radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II (four fraction split-course SBRT)
- description
- Patients undergo 2 fractions of SBRT in weeks 1 and 4
- interventionNames
- Radiation: four fraction split-course SBRT
Primary outcomes (1)
- measure
- Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:
* Low-risk disease - Histopathology score (Gleason sum): =\<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: \<10
* Intermediate-risk disease as either:
* Histopathology score (Gleason sum) =\< 6, T-stage (per current American Joint Committee on Cancer \[AJCC\] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) \> 10 but =\< 20; or
* Histopathology score (Gleason sum) 7 with =\< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA \< 10
* Charlson index of comorbidity score =\< 4
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
* Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
* Patients with a history of pelvic irradiation for any reason
* Life expectancy \< 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
* Prior radiation therapy, brachytherapy, or cryotherapy
* Prior surgical procedure involving peri-rectal and peri-prostatic areaReferences
Publications (0)
Data not yet available
No reference posted for this study.