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Completed

NCT Number: NCT01596816

Hypofractionated Stereotactic Boost in Prostate Cancer

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

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Key information

Conditions

Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Centre Paul Papin, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

First part of treatment : Conformal irradiation

Radiation

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

Fiducials placement

Procedure

Placement of intra-prostatic markers for the tracking

Second part : hypofractionated stereotactic boost

Radiation

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. Sexual toxicity

    Time frame: Up to 5 years after treatment

    According to IIEF5 questionnaire ( International Index of Erectile Function )

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

    Time frame: During the time of treatment

  6. Urinary discomfort

    Time frame: Up to 5 years after treatment

    According to IPSS questionnaire ( International Prostate Symptom Score)

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

    Time frame: During the time of treatment

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

    Time frame: During the time of treatment

  9. Technical criteria : duration of boost

    Time frame: During the treatment

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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study title

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

Acronym: CKNO-PRO

Important dates

Study start
2010
Primary completion
2016
Study completion
2018
First posted
May 11, 2012
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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