Clinical trial · Interventional
Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage
- 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 purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer. The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating 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 Radiosurgery using the Novalis Tx | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiosurgery using NovalisTx
- description
- Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.
- interventionNames
- Radiation: Stereotactic Radiosurgery using the Novalis Tx
Primary outcomes (1)
- measure
- PSA decline measured through laboratory testing.
- timeFrame
- One month following radiosurgery through 5 year follow up
Secondary outcomes (1)
- measure
- Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.
- timeFrame
- One month following radiosurgery through 5 years follow up.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Gleason score ≤ 6 and low volume Gleason 7 (3+4) * PSA \< 10 * Clinical Stage of T2a or less * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Prior radiation treatment for prostate cancer * Gleason score \> 7 * PSA \> 10 * Clinical Stage of T2b or greater
References
Publications (0)
Data not yet available