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Hypofractionated Stereotactic Boost in Prostate Cancer (CKNO-PRO)

Primary Purpose

Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
First part of treatment : Conformal irradiation
Fiducials placement
Second part : hypofractionated stereotactic boost
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre Paul Papin
  • Centre Georges François Leclerc
  • Centre Oscar LAMBRET
  • Centre Léon Bérard
  • Val d'Aurelle-Paul Lamarque
  • Centre Hospitalier Lyon Sud
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Boost by CyberKnife

Boost by linear accelerator

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
Global and metastase-free survival
Time measurement between the inclusion and the date of death/metastatic progression
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.
Sexual toxicity
According to IIEF5 questionnaire ( International Index of Erectile Function )
Technical criteria : Fiducial placement (yes/no)
Urinary discomfort
According to IPSS questionnaire ( International Prostate Symptom Score)
Technical criteria : Cumulative dosimetry (1 time/ 2 times)
Technical criteria : boost schedule (yes/no)
Technical criteria : duration of boost
Time between patient's entry and exit of the radiotherapy treatment room

Full Information

First Posted
June 15, 2011
Last Updated
May 13, 2019
Sponsor
Centre Oscar Lambret
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT01596816
Brief Title
Hypofractionated Stereotactic Boost in Prostate Cancer
Acronym
CKNO-PRO
Official Title
Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2009 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
National Cancer Institute, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boost by CyberKnife
Arm Type
Experimental
Arm Title
Boost by linear accelerator
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
First part of treatment : Conformal irradiation
Intervention Description
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
Intervention Type
Procedure
Intervention Name(s)
Fiducials placement
Intervention Description
Placement of intra-prostatic markers for the tracking
Intervention Type
Radiation
Intervention Name(s)
Second part : hypofractionated stereotactic boost
Intervention Description
3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy
Primary Outcome Measure Information:
Title
Change from baseline in rectal functions
Description
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.
Time Frame
Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Title
Change from baseline in urinary function.
Description
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.
Time Frame
Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Secondary Outcome Measure Information:
Title
Local control of prostate cancer
Description
Local control is defined as: Non progressive PSA according to Phoenix criteria Non progressive clinical examination (DRE) No pathological findings on MRI
Time Frame
3 years
Title
Global and metastase-free survival
Description
Time measurement between the inclusion and the date of death/metastatic progression
Time Frame
Up to 5 years after treatment
Title
PSA kinetics
Description
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.
Time Frame
Between radiotherapy and boost, and after treatment : every 3 months
Title
Sexual toxicity
Description
According to IIEF5 questionnaire ( International Index of Erectile Function )
Time Frame
Up to 5 years after treatment
Title
Technical criteria : Fiducial placement (yes/no)
Time Frame
During the time of treatment
Title
Urinary discomfort
Description
According to IPSS questionnaire ( International Prostate Symptom Score)
Time Frame
Up to 5 years after treatment
Title
Technical criteria : Cumulative dosimetry (1 time/ 2 times)
Time Frame
During the time of treatment
Title
Technical criteria : boost schedule (yes/no)
Time Frame
During the time of treatment
Title
Technical criteria : duration of boost
Description
Time between patient's entry and exit of the radiotherapy treatment room
Time Frame
During the treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric LARTIGAU, MD, PhD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar LAMBRET
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Val d'Aurelle-Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29190707
Citation
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.
Results Reference
derived

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Hypofractionated Stereotactic Boost in Prostate Cancer

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