Clinical Trials Directory

Trials / Unknown

UnknownNCT03284151

Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma

Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma

Status
Unknown
Phase
Study type
Observational
Enrollment
26 (actual)
Sponsor
Centre Francois Baclesse, Luxembourg · Academic / Other
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
RADIATIONCyberknife

Timeline

Start date
2015-01-01
Primary completion
2020-01-01
Completion
2023-01-01
First posted
2017-09-15
Last updated
2022-06-22

Locations

1 site across 1 country: Luxembourg

Source: ClinicalTrials.gov record NCT03284151. Inclusion in this directory is not an endorsement.