Hypofractionated Stereotactic Boost in Prostate Cancer (CKNO-PRO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01596816
First received: June 15, 2011
Last updated: May 28, 2013
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Cancer
Radiation: First part of treatment : Conformal irradiation
Procedure: Fiducials placement
Radiation: Second part : hypofractionated stereotactic boost
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    • 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. [ Time Frame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years ] [ Designated as safety issue: Yes ]
    • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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 Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]
    Time measurement between the inclusion and the date of death/metastatic progression

  • PSA kinetics [ Time Frame: Between radiotherapy and boost, and after treatment : every 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]
    According to IIEF5 questionnaire ( International Index of Erectile Function )

  • Technical criteria : Fiducial placement (yes/no) [ Time Frame: During the time of treatment ] [ Designated as safety issue: No ]
  • Urinary discomfort [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]
    According to IPSS questionnaire ( International Prostate Symptom Score)

  • Technical criteria : Cumulative dosimetry (1 time/ 2 times) [ Time Frame: During the time of treatment ] [ Designated as safety issue: No ]
  • Technical criteria : boost schedule (yes/no) [ Time Frame: During the time of treatment ] [ Designated as safety issue: No ]
  • Technical criteria : duration of boost [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
    Time between patient's entry and exit of the radiotherapy treatment room


Enrollment: 76
Study Start Date: August 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596816

Locations
France
Centre Paul Papin
Angers, France, 49933
Centre Georges François Leclerc
Dijon, France, 21079
Centre Oscar LAMBRET
Lille, France, 59020
Centre Léon Bérard
Lyon, France, 69373
Val d'Aurelle-Paul Lamarque
Montpellier, France, 34298
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Centre Alexis Vautrin
Vandoeuvre Les Nancy, France, 54500
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Eric LARTIGAU, MD, PhD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01596816     History of Changes
Other Study ID Numbers: CKNO-PRO-0901
Study First Received: June 15, 2011
Last Updated: May 28, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 20, 2014