Clinical trial · Interventional
Phase II Study to Evaluate Conventional Radiation Therapy Followed by Radiosurgical Boost in Clinically Localized Prostate Cancer
Phase II Study to Evaluate the Efficacy of Intensity Modulated Radiation Therapy With Hypofractionated Radiosurgical Boosts in the Treatment of Clinically Localized Prostate Cancer
NCT01618851CI-TRIAL-00064143unknownN/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)
This phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients will be treated with three radiosurgical treatments (6.5 Gy per fraction) followed by IMRT (45 Gy in 25 fractions).
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 |
|---|---|---|---|
| Radiotherapy with IMRT and CyberKnife Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT with SBRT Boost
- description
- Patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 Gy per fraction to PTV) followed by IMRT (45 Gy in 25 fractions) over 6-7 weeks.
- interventionNames
- Radiation: Radiotherapy with IMRT and CyberKnife Boost
Primary outcomes (1)
- measure
- Local failure
- timeFrame
- 2 years after radiotherapy.
- description
- To estimate the rate of local failure as assessed by 2 year post-radiotherapy prostate biopsies. (Studies with the CyberKnife radiosurgery would be worthwhile for prostate cancer patients if the rate of local control was \> 70%)
Secondary outcomes (6)
- measure
- Gastrointestinal and genitourinary toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate (Biopsy within one year of enrollment) * Signed Study-Specific COnsent * PSA within 60 days of registration * Baseline AUA score is less than 20 Exclusion Criteria: * Prior Pelvic radiotherapy * Prior Radical Prostate surgery * Recent (within 5 years) or concurrent cancers other than non-melanoma skin cancer * Medical or psychiatric illness that would interfere with treatment or follow-up * Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery.
References
Publications (1)
- DERIVEDDess RT, Devasia TP, Aghdam N, Jackson WC, Soni PD, Smith CP, Mitchell AL, Suy S, Hamstra DA, Jolly S, Nguyen PL, Feng FY, Schipper MJ, Skolarus TA, Miller DC, Wittmann DA, Collins SP, Spratt DE. Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):376-386. doi: 10.1016/j.ijrobp.2018.01.055. Epub 2018 Jan 31. PMID 29487023