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

Phase 2

Terminated

• Conditions: Prostate Cancer With Intermediate Risk

• Registration Number: NCT01039038
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-24
• Last Update Posted: 2011-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre François Baclesse; 🇫🇷 Caen, Basse-normandie, France