Hypofractionated Stereotactic Boost in Prostate Cancer

Cancer Clinical Trial

— CKNO-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596816
• Other study ID #: CKNO-PRO-0901
• Secondary ID: 2010-A00237-32
• Status: Completed
• Phase: Phase 2
• Start date: August 31, 2009
• Est. completion date: September 1, 2018

Study information

• Verified date: May 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 1, 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar LAMBRET	Lille
France	Centre Léon Bérard	Lyon
France	Val d'Aurelle-Paul Lamarque	Montpellier
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Centre Alexis Vautrin	Vandoeuvre Les Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in rectal functions	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.	Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Primary	Change from baseline in urinary function.	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.	Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Secondary	Local control of prostate cancer	Local control is defined as: Non progressive PSA according to Phoenix criteria; Non progressive clinical examination (DRE); No pathological findings on MRI	3 years
Secondary	Global and metastase-free survival	Time measurement between the inclusion and the date of death/metastatic progression	Up to 5 years after treatment
Secondary	PSA kinetics	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.	Between radiotherapy and boost, and after treatment : every 3 months
Secondary	Sexual toxicity	According to IIEF5 questionnaire ( International Index of Erectile Function )	Up to 5 years after treatment
Secondary	Technical criteria : Fiducial placement (yes/no)		During the time of treatment
Secondary	Urinary discomfort	According to IPSS questionnaire ( International Prostate Symptom Score)	Up to 5 years after treatment
Secondary	Technical criteria : Cumulative dosimetry (1 time/ 2 times)		During the time of treatment
Secondary	Technical criteria : boost schedule (yes/no)		During the time of treatment
Secondary	Technical criteria : duration of boost	Time between patient's entry and exit of the radiotherapy treatment room	During the treatment