Clinical trial · Interventional
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
NCT01039038CI-TRIAL-00005818CURIEBOOSTterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer With Intermediate Risk | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| curietherapy and radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- at 5 months
Secondary outcomes (1)
- measure
- 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
- timeFrame
- at 5 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.