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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01039038
Recruitment Status : Terminated (lack of recruitment)
First Posted : December 24, 2009
Last Update Posted : November 28, 2011
Information provided by:
Centre Francois Baclesse

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer With Intermediate Risk Radiation: curietherapy and radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • Radiation: curietherapy and radiotherapy
    boost of curietherapy(40 Gy)and external radiotherapy (34 Gy)

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01039038

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Centre François Baclesse
Caen, Basse-normandie, France, 14000
Sponsors and Collaborators
Centre Francois Baclesse
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Responsible Party: Dr Anne-Catherine COURTECUISSE-DEGRENDEL, Centre François Baclesse Identifier: NCT01039038    
Other Study ID Numbers: CURIEBOOST
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011
Keywords provided by Centre Francois Baclesse:
intermediate risk
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases