Hypofractionated Stereotactic Boost in Prostate Cancer (CKNO-PRO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
INCa (PHRC 2010)
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01596816
First received: June 15, 2011
Last updated: June 20, 2014
Last verified: June 2014
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
INCa (PHRC 2010)
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, 2010-A00237-32
Study First Received: June 15, 2011
Last Updated: June 20, 2014
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 September 11, 2014