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)

Centre Francois Baclesse

Status and phase

Terminated

Phase 2

Conditions

Prostate Cancer With Intermediate Risk

Treatments

Radiation: curietherapy and radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01039038

CURIEBOOST

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Male

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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