Completed
PHASE2
INTERVENTIONAL
NCT01596816
Hypofractionated Stereotactic Boost in Prostate Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
Detailed Description
The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
Interventions
Name:
First part of treatment : Conformal irradiation
Type:
RADIATION
Description:
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
Name:
Fiducials placement
Type:
PROCEDURE
Description:
Placement of intra-prostatic markers for the tracking
Name:
Second part : hypofractionated stereotactic boost
Type:
RADIATION
Description:
3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy
Primary Outcomes
Measure:
Change from baseline in rectal functions
TimeFrame:
Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Description:
* Assessment of rectal toxicity according to the NCI-CTCAE v4.0 scale.
* Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
Measure:
Change from baseline in urinary function.
TimeFrame:
Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Description:
* Assessment of urinary toxicity according to the NCI-CTCAE v4.0 scale.
* Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
Trial Information
NCT ID
NCT01596816
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Centre Oscar Lambret
Last Updated
December 15, 2025