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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01039038

Acronym

CURIEBOOST

Enrollment

Registered

2009-12-24

Start date

2009-09-30

Completion date

2011-11-30

Last updated

2011-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer With Intermediate Risk

Keywords

prostate, curietherapy, radiotherapy, intermediate risk

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.

Interventions

RADIATIONcurietherapy and radiotherapy

boost of curietherapy(40 Gy)and external radiotherapy (34 Gy)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026