Clinical trial · Interventional
Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer
Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate 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)
The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.
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 Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "TrueBeam" stereotactic body radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 36.25Gy to prostate in 5 fractions
- description
- 36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.
- interventionNames
- Radiation: "TrueBeam" stereotactic body radiosurgery
Primary outcomes (1)
- measure
- acute and late GI/GU toxicity rate following treatment
- timeFrame
- 5 years
- description
- The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven prostate adenocarcinoma within 1 year of enrollment * Low risk: Gleason \<or=6 \& PSA \<or=10 \& Clinical Stage T1b-T2a,Nx or N0, Mx or M0 * Intermediate risk:Gleason \<or=6 \& PSA\<or=10 \& Clinical Stage T2b OR Gleason=7 \& PSA\<or=10 \& Clinical Stage T1b-T2b OR Gleason \<or=6 \& PSA \> 10 \& \< or =20 \& Clinical Stage T1b- T2b, Nx or NO, Mx or M0 * ECOG Performance Status 0-1 * No prior prostate radiation or other definitive therapy Exclusion Criteria: * implanted hardware or other material that would prohibit treatment planning or delivery * chemotherapy for a malignancy within the previous 5 years * history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years * hormone ablation for 2 months prior to treatment or during treatment
References
Publications (1)
- BACKGROUNDKing CR, Lehmann J, Adler JR, Hai J. CyberKnife radiotherapy for localized prostate cancer: rationale and technical feasibility. Technol Cancer Res Treat. 2003 Feb;2(1):25-30. doi: 10.1177/153303460300200104. PMID 12625751