Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study Evaluating the Feasibility of a Dose Increase by a Boost of Curietherapy in PDR Associated With the Extern Radiotherapy in Intermediate Risk in the Prostate Cancer

Conditions
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Prostate Cancer With Intermediate Risk

Intervention / Treatment
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* Radiation: curietherapy and radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Adenocarcinoma not histologically proven Metastases presence 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: curietherapy and radiotherapy|boost of curietherapy(40 Gy)and external radiotherapy (34 Gy)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, curietherapy, radiotherapy, intermediate risk