Clinical trial · Observational
CyberKnife for Prostate Cancer Patients Aged 70 y or More
Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More
- 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)
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly. Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) \<30ng/ml. Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5 fractions, in 10 days, considering CAPRA Scores\>5. Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Acute and late toxicity (Using the CTCAEv4)
- timeFrame
- During 36 months after treatment
- description
- Using the CTCAEv4
Secondary outcomes (5)
- measure
- PSA evaluation
- timeFrame
- at 4 and 6 months, than every 6 months for 3 years
- description
- PSA Dosage
- measure
- Digital rectal exam
- timeFrame
- at 6, 12, 24 and 36 months
- description
- Clinical examination (digital rectal exam)
- measure
- Birads score evaluation
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * T1-T3b, * MRI pelvic nodes negative, * M0, * any Gleason Score, * PSA\<30ng/ml, * WHO (World Health Organisation) score\<2, IPSS≤15, * maximal urinary flow rate ≥15ml/s, * mean urinary flow rate ≥5ml/s, * multiparametric prostatic and pelvis MRI Exclusion Criteria: * Prostatic volume \> 100cc, * TURP (transurethral prostatectomy) \<3 y, * any recurrent prostatitis within the last 3 years, * collagenose diseases, * ulcero-haemorrhagic rectocolitis or * crohn diseases
References
Publications (3)
- RESULTNickers P, Hermesse J, Deneufbourg JM, Vanbelle S, Lartigau E. Which alpha/beta ratio and half-time of repair are useful for predicting outcomes in prostate cancer? Radiother Oncol. 2010 Dec;97(3):462-6. doi: 10.1016/j.radonc.2010.06.006. Epub 2010 Aug 17. PMID 20724012
- RESULTBoike TP, Lotan Y, Cho LC, Brindle J, DeRose P, Xie XJ, Yan J, Foster R, Pistenmaa D, Perkins A, Cooley S, Timmerman R. Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. J Clin Oncol. 2011 May 20;29(15):2020-6. doi: 10.1200/JCO.2010.31.4377. Epub 2011 Apr 4. PMID 21464418
- RESULTKing CR, Brooks JD, Gill H, Presti JC Jr. Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):877-82. doi: 10.1016/j.ijrobp.2010.11.054. Epub 2011 Feb 6. PMID 21300474