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)

November 24, 2011 updated by: Centre Francois Baclesse

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse-normandie
      • Caen, Basse-normandie, France, 14000
        • Centre Francois Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: at 5 months
at 5 months

Secondary Outcome Measures

Outcome Measure
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
Time Frame: at 5 months
at 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

November 28, 2011

Last Update Submitted That Met QC Criteria

November 24, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CURIEBOOST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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