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

Prostate Cancer With Intermediate Risk Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01039038
• Other study ID #: CURIEBOOST
• Status: Terminated
• Phase: Phase 2
• First received: December 11, 2009
• Last updated: November 24, 2011
• Start date: September 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer With Intermediate Risk
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen	Basse-normandie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		at 5 months	Yes
Secondary	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		at 5 months	Yes