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Clinical Trial Summary

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.


Clinical Trial Description

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure. Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores). Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland. Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced. Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35<2cc. Bladder neck and urethra: V35<1cc. Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03284151
Study type Observational [Patient Registry]
Source Centre Francois Baclesse, Luxembourg
Contact
Status Active, not recruiting
Phase
Start date January 2015
Completion date January 2023

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