Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer (CURIEBOOST)
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ClinicalTrials.gov Identifier: NCT01039038
Recruitment Status :
(lack of recruitment)
The objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer.
Proportion of patients with a delivered dose by a boost of curietherapy is at least 40 Gy (D95) associated to a dose of 34 Gy for extern radiotherapy [ Time Frame: at 5 months ]
Secondary Outcome Measures :
Acute toxicities at month 3 after end of treatment: late toxicities, survival without biological relapse, without local relapse or metastatic evolution, feasibility of MRI use in prostatic CTV [ Time Frame: at 5 months ]
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Layout table for eligibility information
Ages Eligible for Study:
50 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age ≥ 50 years and ≤ 75 years
Life expectancy >10 years
Localized prostatic adenocarcinoma and histologically proven
Intermediate risk cancer(T2b or PSA between 10 and 20 or Gleason = 7(3+4) according to Amico criteria
Metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
OMS < 2
No previous treatment by radiotherapy and/or curietherapy
Hormonotherapy authorized before and during the study
Rectal or uretero-vesical pathology
Signed informed consent
Social security system affiliation
Individual deprived of liberty or placed under the authority of a tutor.
No anesthesia contraindication
Adenocarcinoma not histologically proven
Pathological nodes presence(≥ 10 mm)
Prior prostate endoscopic resection
history of other malignancy except for appropriately treated superficial basal cell skin cancer
Medical contraindications to anesthesia
Patients with uncontrolled psychiatric disease or medical disease incompatible with the protocol
Impossibility to respect the medical follow-up of the protocol for geographical, social or psychic reasons