Clinical trial NCT01596816: Hypofractionated Stereotactic Boost in Prostate Cancer
Official title: Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: prostate cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2012-05-11
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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)

Primary outcomes:
measure: Change from baseline in rectal functions
timeFrame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
measure: Change from baseline in urinary function.
timeFrame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Secondary outcomes:
measure: Local control of prostate cancer
timeFrame: 3 years
measure: Global and metastase-free survival
timeFrame: Up to 5 years after treatment
measure: PSA kinetics
timeFrame: Between radiotherapy and boost, and after treatment : every 3 months
measure: Sexual toxicity
timeFrame: Up to 5 years after treatment
measure: Technical criteria : Fiducial placement (yes/no)
timeFrame: During the time of treatment
measure: Urinary discomfort
timeFrame: Up to 5 years after treatment
measure: Technical criteria : Cumulative dosimetry (1 time/ 2 times)
timeFrame: During the time of treatment
measure: Technical criteria : boost schedule (yes/no)
timeFrame: During the time of treatment
measure: Technical criteria : duration of boost
timeFrame: During the treatment
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar LAMBRET
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Val d'Aurelle-Paul Lamarque
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Oscar Lambret
name: Eric LARTIGAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pasquier D, Nickers P, Peiffert D, Maingon P, Pommier P, Lacornerie T, Martinage G, Tresch E, Lartigau E. Hypofractionated stereotactic boost in intermediate risk prostate carcinoma: Preliminary results of a multicenter phase II trial (CKNO-PRO). PLoS One. 2017 Nov 30;12(11):e0187794. doi: 10.1371/journal.pone.0187794. eCollection 2017.