CyberKnife for Prostate Cancer Patients Aged 70 y or More
NCT ID: NCT03235557
Last Updated: 2022-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2014-10-31
2021-12-31
Brief Summary
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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.
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Detailed Description
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Rationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now curative treatments were not proven to increase overall survival rates. Therefore, very short, comfortable and safe treatments have to be designed to increase the pelvic control of the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using hypofractionation schemes.
Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response and quality of life evaluation.
Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA\<30ng/ml.
Dose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5 fractions, in 10 days, considering CAPRA Scores\>5.
Doses to the Organs At Risk (OAR) : Rectum wall : V36.25\<2%, V27\<20%, V23\<30%, V20\<35%. Bladder wall : V36.25\<2%, V27\<20%, V20\<35%. Considering specifically the prescription of 37.5 Gray, the rectum and bladder wall: V37.5\<2%. Anytime, hot spots of 105 % of the prescription dose must avoid the urethra.
Evaluation criteria : CTCAEV4 (Common Toxicity Criteria for Adverse Events, version4), PSA, multiparametric MRI, IPSS (International Prostate Score Symptom) and IIEF5 (International Index of Erectile Function).
Methodolgy : this is a three step prospective, observational study of 20 patients each step. Before moving to the next step, the severe acute or late toxicity at a median follow-up of 1 year must remain below 5% each.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* TURP (transurethral prostatectomy) \<3 y,
* any recurrent prostatitis within the last 3 years,
* collagenose diseases,
* ulcero-haemorrhagic rectocolitis or
* crohn diseases
70 Years
MALE
No
Sponsors
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Centre Francois Baclesse, Luxembourg
OTHER
Responsible Party
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Principal Investigators
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Philippe Nickers, MD, PhD
Role: STUDY_CHAIR
Centre Francois Baclesse
Michel Untereiner, MD
Role: STUDY_DIRECTOR
Centre Francois Baclesse
Locations
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Centre Francois Baclesse
Esch-sur-Alzette, , Luxembourg
Countries
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References
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Nickers 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.
Boike 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.
King 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.
Other Identifiers
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CYM Prostate CFB 1
Identifier Type: -
Identifier Source: org_study_id
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