An observational study in Prostate Cancer, sponsored by Centre Francois Baclesse, Luxembourg. Status unknown at 1 site in Luxembourg. Open to male participants. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Centre Francois Baclesse, Luxembourg · Observational
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 26 is below the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Centre Francois Baclesse, Luxembourg is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Prostatic adenocarcinoma Capra≤2
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Delay between the initial diagnosis and date of salvage treatment
Delay between the initial diagnosis and date of salvage treatment
Time frame: through study completion, up to 36 months
PSA evaluation
PSA dosage
Time frame: 3, 6, 12, 18, 24, 30, 36 months
Birads score evaluation
Multiparametric prostatic MRI
Time frame: 12, 24, 36 months
Acute and late toxicity
Acute and late toxicity using the CTCAEv4
Time frame: 3, 6, 12, 18, 24, 30, 36 months
IPSS evaluation
IPSS score
Time frame: 12, 24, 36 months
IIEF5 evaluation
IIEF5 score
Time frame: 12, 24, 36 months
The record gives a start of Jan 2015, a primary completion of Jan 2020 and a completion of Jan 2023. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Centre Francois Baclesse, Luxembourg