Hypofractionated Stereotactic Boost in Prostate Cancer (CKNO-PRO)

Centre Oscar Lambret

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Radiation: First part of treatment : Conformal irradiation; Radiation: Second part : hypofractionated stereotactic boost; Procedure: Fiducials placement

Study type: Interventional

Funder types: Other

Identifiers

NCT01596816

2010-A00237-32 (Other Identifier)

CKNO-PRO-0901

Details and patient eligibility

About

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

Full description

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

Enrollment: 76 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Boost by CyberKnife

Experimental group

Treatment:

Radiation: First part of treatment : Conformal irradiation

Radiation: Second part : hypofractionated stereotactic boost

Procedure: Fiducials placement

Boost by linear accelerator

Experimental group

Treatment:

Radiation: First part of treatment : Conformal irradiation

Radiation: Second part : hypofractionated stereotactic boost

Procedure: Fiducials placement