Back to resultsFeasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer (CURIEBOOST)
Primary Purpose
Prostate Cancer With Intermediate Risk
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
curietherapy and radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer With Intermediate Risk focused on measuring prostate, curietherapy, radiotherapy, intermediate risk
Eligibility 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
Sites / Locations
- Centre François Baclesse
Outcomes
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
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
Full Information
NCT ID
NCT01039038
First Posted
December 11, 2009
Last Updated
November 24, 2011
Sponsor
Centre Francois Baclesse
1. Study Identification
Unique Protocol Identification Number
NCT01039038
Brief Title
Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer
Acronym
CURIEBOOST
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 Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer With Intermediate Risk
Keywords
prostate, curietherapy, radiotherapy, intermediate risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
curietherapy and radiotherapy
Intervention Description
boost of curietherapy(40 Gy)and external radiotherapy (34 Gy)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
State/Province
Basse-normandie
ZIP/Postal Code
14000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer
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