Hypofractionated Stereotactic Boost in Prostate Cancer
CKNO-PRO
Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study
2 other identifiers
interventional
76
1 country
7
Brief Summary
hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cancer
Started Aug 2010
Longer than P75 for phase_2 cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2010
CompletedFirst Submitted
Initial submission to the registry
June 15, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedMarch 13, 2026
March 1, 2026
6 years
June 15, 2011
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in rectal functions
* Assessment of rectal toxicity according to the NCI-CTCAE v4.0 scale. * Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Change from baseline in urinary function.
* Assessment of urinary toxicity according to the NCI-CTCAE v4.0 scale. * Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Secondary Outcomes (9)
Local control of prostate cancer
3 years
Global and metastase-free survival
Up to 5 years after treatment
PSA kinetics
Between radiotherapy and boost, and after treatment : every 3 months
Sexual toxicity
Up to 5 years after treatment
Technical criteria : Fiducial placement (yes/no)
During the time of treatment
- +4 more secondary outcomes
Study Arms (2)
Boost by CyberKnife
EXPERIMENTALBoost by linear accelerator
EXPERIMENTALInterventions
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
Placement of intra-prostatic markers for the tracking
3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- National Cancer Institute, Francecollaborator
Study Sites (7)
Centre Paul Papin
Angers, 49933, France
Centre Georges François Leclerc
Dijon, 21079, France
Centre Oscar LAMBRET
Lille, 59020, France
Centre Léon Bérard
Lyon, 69373, France
Val d'Aurelle-Paul Lamarque
Montpellier, 34298, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500, France
Related Publications (1)
Pasquier 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: 29190707DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric LARTIGAU, MD, PhD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2011
First Posted
May 11, 2012
Study Start
August 31, 2010
Primary Completion
September 1, 2016
Study Completion
September 1, 2018
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share