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CancerPhase 2CKNO-PRONCT01596816

Hypofractionated Stereotactic Boost in Prostate Cancer

A Phase 2 study testing First part of treatment : Conformal irradiation, Fiducials placement and Second part : hypofractionated stereotactic boost in people with Cancer, run by Centre Oscar Lambret at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cancer
What is being tested?
First part of treatment : Conformal irradiation, Fiducials placement and Second part : hypofractionated stereotactic boost
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
7 sitesFrance
Study dates
31 Aug 2010to 1 Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • Centre Paul Papin

    Angers, 49933

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Oscar LAMBRET

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Val d'Aurelle-Paul Lamarque

    Montpellier, 34298

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

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

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

Read the detailed description

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

Conditions
Cancer
Being tested
First part of treatment : Conformal irradiation, Fiducials placement, Second part : hypofractionated stereotactic boost
Keywords
prostate cancer
Medical subject headings
Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • First part of treatment : Conformal irradiationRadiation

    23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy

  • Fiducials placementProcedure or surgery

    Placement of intra-prostatic markers for the tracking

  • Second part : hypofractionated stereotactic boostRadiation

    3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy

Study groups in NCT01596816
Study groupRoleWhat they receive
Boost by CyberKnifeExperimentalNot described
Receives: Radiation: First part of treatment : Conformal irradiation; Procedure: Fiducials placement; Radiation: Second part : hypofractionated stereotactic boost
Boost by linear acceleratorExperimentalNot described
Receives: Radiation: First part of treatment : Conformal irradiation; Procedure: Fiducials placement; Radiation: Second part : hypofractionated stereotactic boost

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years

  2. 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.

    Measured: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years

Secondary outcomes (9)

  1. Local control of prostate cancer

    Local control is defined as:

    • Non progressive PSA according to Phoenix criteria
    • Non progressive clinical examination (DRE)
    • No pathological findings on MRI

    Measured: 3 years

  2. Global and metastase-free survival

    Time measurement between the inclusion and the date of death/metastatic progression

    Measured: Up to 5 years after treatment

  3. PSA kinetics

    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.

    Measured: Between radiotherapy and boost, and after treatment : every 3 months

  4. Sexual toxicity

    According to IIEF5 questionnaire ( International Index of Erectile Function )

    Measured: Up to 5 years after treatment

  5. Technical criteria : Fiducial placement (yes/no)

    Measured: During the time of treatment

  6. Urinary discomfort

    According to IPSS questionnaire ( International Prostate Symptom Score)

    Measured: Up to 5 years after treatment

  7. Technical criteria : Cumulative dosimetry (1 time/ 2 times)

    Measured: During the time of treatment

  8. Technical criteria : boost schedule (yes/no)

    Measured: During the time of treatment

  9. Technical criteria : duration of boost

    Time between patient's entry and exit of the radiotherapy treatment room

    Measured: During the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2012 (estimated)
  2. Study start31 Aug 2010
  3. Primary completionSep 2016
  4. Study completion1 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01596816
Sponsor's protocol ID
CKNO-PRO-0901
Other IDs
2010-A00237-32
Acronym
CKNO-PRO
Status last verified
Mar 2026
First submitted
15 Jun 2011
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29190707

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing First part of treatment : Conformal irradiation, Fiducials placement and Second part : hypofractionated stereotactic boost in people with Cancer, run by Centre Oscar Lambret at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01596816, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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