Clinical trial · Interventional
Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer
Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
NCT00619515CI-TRIAL-00040213terminatedN/AResults postedClinicalTrials.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): Prematurely terminated at institution request
Summary
Brief summary (as posted)
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| implanted fiducial-based imaging | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CyberKnife® stereotactic radiosurgery
- interventionNames
- Other: questionnaire administration
- Procedure: implanted fiducial-based imaging
- Radiation: stereotactic radiosurgery
Primary outcomes (1)
- measure
- Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
- timeFrame
- Within 90 days of completing treatment
- description
- This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.
Secondary outcomes (8)
- measure
- Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Disease confirmed by biopsy within 1 year of study entry
* Gleason score 2-7(3+4)
* Clinical stage T1a or T2b, N0 or NX, M0 or MX
* T- stage and N-stage determined by physical exam and available imaging studies (i.e., ultrasound, CT scan, and/or MRI)
* M-stage determined by physical exam, CT scan, and/or MRI
* Bone scan is not required unless clinical findings suggest possible osseous metastases
* PSA ≤ 10 ng/mL within the past 60 days
* At risk for recurrence, as defined by 1 of the following risk groups:
* Low-risk, defined by the following combination:
* Stage T1a-T2a, Gleason 2-6, and PSA ≤ 10 ng/mL
* Low- to-Intermediate-risk, defined by either of the following combinations:
* Stage T2b, Gleason 2-6, and PSA ≤ 10 ng/mL
* Stage T2b, Gleason 3+4=7, and PSA ≤ 10 ng/mL
* Prostate volume must be ≤ 100 cc
* Determined by measurement from CT scan or ultrasound within the past 90 days or within the past 14 days if hormone therapy is given
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
PRIOR CONCURRENT THERAPY:
* No prior definitive therapy for prostate cancer, including prostatectomy, cryotherapy, or radiotherapy to the prostate or lower pelvis
* No more than 6 months of hormone ablation for gland downsizingReferences
Publications (0)
Data not yet available
No reference posted for this study.