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Surgery Combined With Intensity Modulated Radiation Therapy - Image-Guided Radiation Therapy (IMRT-IGRT) in Locally-advanced Prostate Cancers

NCT01148069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-12-19

No results posted yet for this study

Summary

Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate:

* pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV);
* a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).

Conditions

Interventions

PROCEDURE

Surgery combined with IMRT-IGRT

Patients will have surgery consisting in extensive pelvic dissection and ablation of seminal vesicles. Surgery will be followed by prolonged hormonotherapy (3 years) associated, after 2 months, with prostatic only irradiation.

Sponsors & Collaborators

  • Center Eugene Marquis

    collaborator OTHER

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Renaud DE CREVOISIER, MD, PhD · Rennes CRLCC Eugène Marquis

  • Sebastien VINCENDEAU, MD · Rennes University Hospital

  • Eric BELLISSANT, MD, PhD · Rennes University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-30
Primary Completion
2018-07-04
Completion
2018-07-04

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01148069 on ClinicalTrials.gov