Status:
COMPLETED
Surgery Combined With Intensity Modulated Radiation Therapy - Image-Guided Radiation Therapy (IMRT-IGRT) in Locally-advanced Prostate Cancers
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Center Eugene Marquis
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 u...
Detailed Description
This study targets non metastatic prostatic locally-advanced adenocarcinomas which are at high risk of both local progression and metastases. The standard treatment of these tumours associates externa...
Eligibility Criteria
Inclusion
- Age \> 18,
- Prostate adenocarcinoma (histologically proven),
- Locally-advanced (T3a or Gleason \> 7 or PSA ≥ 20 ng/mL),
- Distal half of seminal vesicles unaffected on MRI,
- Non metastatic cancer: negative extension assessment (on prostatic and pelvic MRI and bone scintigraphy),
- Radiotherapy and hormonotherapy indication,
- Medical insurance affiliation,
- Written informed consent.
- Non-inclusion criteria:
- Co-morbidity or medical history contraindicating surgery (pelvic lymphadenectomy and seminal vesicle ablation),
- Contraindication to pelvic irradiation,
- Hip prosthesis,
- History of cancer for the last 5 years (except baso-cellular epithelioma),
- History of pelvic irradiation,
- Person deprived of freedom or under guardianship,
- Participation in another biomedical research.
Exclusion
- Surgery showing lymph nodes involvement (pelvic radiation indication)
- Surgery without ablation of seminal vesicles
- Surgery with positive margins in seminal vesicles
Key Trial Info
Start Date :
July 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2018
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01148069
Start Date
July 30 2010
End Date
July 4 2018
Last Update
December 19 2018
Active Locations (2)
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1
Service d'Urologie - Hôpital de Pontchaillou
Rennes, France, 35033
2
Centre Eugène Marquis - CRLCC
Rennes, France, 35042