Hypofractionated Stereotactic Boost in Prostate Cancer

Phase 2

Completed

• Conditions: Cancer
• Interventions: Procedure: Fiducials placement

• Registration Number: NCT01596816
• Lead Sponsor: Centre Oscar Lambret

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).

Study Timeline

• Study Start: 2009-08-31
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Primary Completion: 2016-09
• Study Completion: 2018-09-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boost by CyberKnife	Fiducials placement	-
Boost by linear accelerator	Fiducials placement	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in rectal functions	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.
Change from baseline in urinary function.	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 Outcome Measures

Name	Time	Method
Local control of prostate cancer	3 years	Local control is defined as: * Non progressive PSA according to Phoenix criteria; * Non progressive clinical examination (DRE); * No pathological findings on MRI
PSA kinetics	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.
Technical criteria : Fiducial placement (yes/no)	During the time of treatment
Urinary discomfort	Up to 5 years after treatment	According to IPSS questionnaire ( International Prostate Symptom Score)
Technical criteria : Cumulative dosimetry (1 time/ 2 times)	During the time of treatment
Technical criteria : duration of boost	During the treatment	Time between patient's entry and exit of the radiotherapy treatment room
Sexual toxicity	Up to 5 years after treatment	According to IIEF5 questionnaire ( International Index of Erectile Function )
Technical criteria : boost schedule (yes/no)	During the time of treatment
Global and metastase-free survival	Up to 5 years after treatment	Time measurement between the inclusion and the date of death/metastatic progression

Trial Locations

Locations (7)

Centre Léon Bérard; 🇫🇷 Lyon, France

Val d'Aurelle-Paul Lamarque; 🇫🇷 Montpellier, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre Les Nancy, France

Centre Oscar LAMBRET; 🇫🇷 Lille, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France