Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01039038
• Date of registration: 11/12/2009
• Prospective Registration: No
• Primary sponsor: Centre Francois Baclesse
• Public 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 CURIEBOOST
• Scientific 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
• Date of first enrolment: September 2009
• Target sample size: 50
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01039038
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 75 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer With Intermediate Risk

Intervention(s)

Radiation: curietherapy and radiotherapy

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

CURIEBOOST

Source(s) of Monetary Support

Please refer to primary and secondary sponsors