Clinical trial · Interventional
CyberKnife Dose Escalation Prostate Cancer Trial
CyberKnife Dose Escalation for Unfavorable and High-risk Prostate Cancer
NCT03822494CI-TRIAL-00086307CK-DESPOTactive not recruitingN/AClinicalTrials.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)
Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate cancer. Multiple single institution experiences suggest high biochemical control rates with acceptable toxicity in low risk prostate cancer but efficacy data in unfavorable type prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate radiation dose delivery to the prostate while sparing normal tissue.
Conditions
Conditions (3)
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 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalated CyberKnife SBRT
- description
- DE-SBRT will be delivered using the CyberKnife robotic radiosurgery system. Patients will be treated with five SBRT treatments (8 Gy per fraction to the PTV, and 9-10 Gy per fraction to any nodules identified on endorectal MRI) over 7-10 days.
- interventionNames
- Radiation: CyberKnife SBRT
Primary outcomes (1)
- measure
- Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0
- timeFrame
- 24 Months
- description
- Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using
Secondary outcomes (6)
- measure
- Biochemical Disease Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate diagnosed within 360 days of enrollment. * Prostate Specific Antigen (PSA) documented within 90 days prior to registration. * Clinical staging completed within 90 days of registration. * No Nodal or Distant Metastases documented on CT or MRI of the pelvis and bone scan. * Unfavorable Risk Prostate Carcinoma as Described is documented. * No prior pelvic radiotherapy. * No prior Trans-urethral resection of the prostate (TURP). * Prostate volume \< 100 cc * American Urologic Association (AUA) score \< 20 * No recent (within 5 years) or concurrent cancers other than non-melanoma skin cancers. * Patient must have no medical or psychiatric illnesses that would interfere with treatment or follow-up. * No implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and treatment delivery is allowed. * Candidate for rectal spacer placement Exclusion Criteria: * Other cancer diagnosis other than non-melanoma skin cancer with 5 years * Prostate size greater than 100cc * AUA greater than 20 * Implanted hardware impacting imaging * Metastatic prostate cancer * Contraindication to hormone therapy
References
Publications (0)
Data not yet available
No reference posted for this study.