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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


Phase 2
50 Years
75 Years
Not Enrolling
Male
Prostate Cancer With Intermediate Risk

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

at 5 months

Safety Issue:

Yes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CURIEBOOST

NCT ID:

NCT01039038

Start Date:

September 2009

Completion Date:

November 2011

Related Keywords:

  • Prostate Cancer With Intermediate Risk
  • prostate
  • curietherapy
  • radiotherapy
  • intermediate risk
  • Prostatic Neoplasms

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