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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)

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01039038
First received: December 11, 2009
Last updated: November 24, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer With Intermediate Risk
 Radiation: curietherapy and radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: curietherapy and radiotherapy
    boost of curietherapy(40 Gy)and external radiotherapy (34 Gy)
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039038

Locations
France
Centre François Baclesse
Caen, Basse-normandie, France, 14000
Sponsors and Collaborators
Centre Francois Baclesse
  More Information

No publications provided

Responsible Party: Dr Anne-Catherine COURTECUISSE-DEGRENDEL, Centre François Baclesse
ClinicalTrials.gov Identifier: NCT01039038     History of Changes
Other Study ID Numbers: CURIEBOOST
Study First Received: December 11, 2009
Last Updated: November 24, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
prostate
curietherapy
radiotherapy
intermediate risk

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013