Clinical trial · Interventional
Hypofractionated Stereotactic Boost in Prostate Cancer
Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study
NCT01596816CI-TRIAL-00105392CKNO-PROcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fiducials placement | Procedure | — | UNRESOLVED |
| First part of treatment : Conformal irradiation | Radiation | — | UNRESOLVED |
| Second part : hypofractionated stereotactic boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Boost by CyberKnife
- interventionNames
- Radiation: First part of treatment : Conformal irradiation
- Procedure: Fiducials placement
- Radiation: Second part : hypofractionated stereotactic boost
- type
- EXPERIMENTAL
- label
- Boost by linear accelerator
- interventionNames
- Radiation: First part of treatment : Conformal irradiation
- Procedure: Fiducials placement
- Radiation: Second part : hypofractionated stereotactic boost
Primary outcomes (2)
- measure
- Change from baseline in rectal functions
- timeFrame
- Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate adenocarcinoma proved by histology * With at least one of this intermediate-risk criterias: * T2b * and/or PSA between 10 et 20 ng/ml * and/or Gleason score = 7 * Prostatic volume ≤ 80 cc * No adenopathy(lymph node \< 1.5 cm on scanner or MRI and/or in lymph node dissection) * No metastasis (bone scan) * Age \>= 18 ans * No prior pelvic irradiation * No prior anticancer treatment (prostatectomy, chemotherapy, hormonotherapy \> 3 months) * Performance status (ECOG) \< 1 * No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation * Life expectancy \>= 10 weeks * Patient affiliated to health insurance * Informed consent signed by the patient Exclusion Criteria: * Cancer no histologically proved * Unfavorable-risk(T2c and/or PSA \> 20 ng/ml and/or Gleason \> 7) * Favorable-risk(T1c T2a and PSA \< 10 ng/ml and Gleason \< 7) * T3 and T4 * History of cancer uncontrolled and/or treated since less of 5 years (except basal cell carcinoma of the skin) * Contraindication to MRI * IPSS score \> 10 * Recurrent or metastatic disease * Allergy to gold * Patient already included in another therapeutic trial with an experimental molecule * Unable for medical follow-up (geographic, social or mental reasons)
References
Publications (1)
- DERIVEDPasquier D, Nickers P, Peiffert D, Maingon P, Pommier P, Lacornerie T, Martinage G, Tresch E, Lartigau E. Hypofractionated stereotactic boost in intermediate risk prostate carcinoma: Preliminary results of a multicenter phase II trial (CKNO-PRO). PLoS One. 2017 Nov 30;12(11):e0187794. doi: 10.1371/journal.pone.0187794. eCollection 2017. PMID 29190707