Hypofractionated Stereotactic Boost in Prostate Cancer (CKNO-PRO)

March 12, 2026 updated by: Centre Oscar Lambret

Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study

hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Centre Paul Papin
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Montpellier, France, 34298
        • Val d'Aurelle-Paul Lamarque
      • Pierre-Bénite, France, 69310
        • Centre Hospitalier Lyon Sud
      • Vandœuvre-lès-Nancy, France, 54500
        • Centre Alexis Vautrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Boost by CyberKnife
Radiation: First part of treatment : Conformal irradiation
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
Procedure: Fiducials placement
Placement of intra-prostatic markers for the tracking
Radiation: Second part : hypofractionated stereotactic boost
3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy
Experimental: Boost by linear accelerator
Radiation: First part of treatment : Conformal irradiation
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
Procedure: Fiducials placement
Placement of intra-prostatic markers for the tracking
Radiation: Second part : hypofractionated stereotactic boost
3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in rectal functions
Time Frame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
  • 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.
Time Frame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control of prostate cancer
Time Frame: 3 years

Local control is defined as:

  • Non progressive PSA according to Phoenix criteria
  • Non progressive clinical examination (DRE)
  • No pathological findings on MRI
3 years
Global and metastase-free survival
Time Frame: Up to 5 years after treatment
Time measurement between the inclusion and the date of death/metastatic progression
Up to 5 years after treatment
PSA kinetics
Time Frame: Between radiotherapy and boost, and after treatment : every 3 months
Comparison of the PSA dosage before, at the end of treatment then every 3 months. The PSA dosage evolution will be correlate with the local control treatment.
Between radiotherapy and boost, and after treatment : every 3 months
Sexual toxicity
Time Frame: Up to 5 years after treatment
According to IIEF5 questionnaire ( International Index of Erectile Function )
Up to 5 years after treatment
Technical criteria : Fiducial placement (yes/no)
Time Frame: During the time of treatment
During the time of treatment
Urinary discomfort
Time Frame: Up to 5 years after treatment
According to IPSS questionnaire ( International Prostate Symptom Score)
Up to 5 years after treatment
Technical criteria : Cumulative dosimetry (1 time/ 2 times)
Time Frame: During the time of treatment
During the time of treatment
Technical criteria : boost schedule (yes/no)
Time Frame: During the time of treatment
During the time of treatment
Technical criteria : duration of boost
Time Frame: During the treatment
Time between patient's entry and exit of the radiotherapy treatment room
During the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

National Cancer Institute, France

Investigators

  • Principal Investigator: Eric LARTIGAU, MD, PhD, Centre Oscar Lambret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2010

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimated)

May 11, 2012

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKNO-PRO-0901
  • 2010-A00237-32 (Other Identifier: IDRCB Number (ANSM_DEDIM))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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