Clinical trial · Interventional
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment. The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy boost with external beam radiotherapy | Radiation | — | UNRESOLVED |
| Exclusive external beam radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brachytherapy boost
- description
- Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique
- interventionNames
- Radiation: Brachytherapy boost with external beam radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Exclusive external beam irradiation
- description
- Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.
- interventionNames
- Radiation: Exclusive external beam radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 80 years; * life expectancy of greater than 10 years; * prostate adenocarcinoma histologically proven; * prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-2. * the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006); * the signed consent form. Exclusion Criteria: * PSA level \> 20; * Gleason \> 7; * clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion); * prostate volume \> 60 cc; * pelvic lymph nodes involvement at dissection or imaging (ADP \> 1.5 cm); * concurrent hormone therapy; * the presence of distant metastasis (M1); * history of abdominal or pelvic irradiation; * history of prostate resection in the previous 6 months and/or not allowing the implantation of markers; * history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma); * urinary discomfort with an IPSS (International Prostate Symptom Score) \> 15 (without alpha-blocking); * inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease; * other undergoing study that may interfere with the present study; * patient under legal protection measure.
References
Publications (0)
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